Trial Outcomes & Findings for The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV) (NCT NCT00279201)
NCT ID: NCT00279201
Last Updated: 2011-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2091 participants
Primary outcome timeframe
Endpoint (Initiation: Week 24)
Results posted on
2011-02-21
Participant Flow
Initiation: Glargine or Lispro LM - 24 weeks. Maintenance: Up to 2 more years treatment if HbA1c \<=7.0 at 24 weeks. After Initiation, if HbA1c \>7.0 after 24 weeks, instead of entering Maintenance, those from Lispro LM could receive Basal bolus or Mid Mix; glargine could receive Basal bolus or Lispro LM for 24 weeks in Intensification Addendum.
Participant milestones
| Measure |
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
|
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
|
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
|
Lispro Low Mix Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|---|---|
|
Initiation
STARTED
|
1046
|
1045
|
0
|
0
|
0
|
0
|
|
Initiation
COMPLETED
|
918
|
900
|
0
|
0
|
0
|
0
|
|
Initiation
NOT COMPLETED
|
128
|
145
|
0
|
0
|
0
|
0
|
|
Maintenance
STARTED
|
419
|
473
|
0
|
0
|
0
|
0
|
|
Maintenance
COMPLETED
|
188
|
239
|
0
|
0
|
0
|
0
|
|
Maintenance
NOT COMPLETED
|
231
|
234
|
0
|
0
|
0
|
0
|
|
Intensification Addendum
STARTED
|
0
|
0
|
174
|
200
|
171
|
199
|
|
Intensification Addendum
COMPLETED
|
0
|
0
|
151
|
172
|
142
|
162
|
|
Intensification Addendum
NOT COMPLETED
|
0
|
0
|
23
|
28
|
29
|
37
|
Reasons for withdrawal
| Measure |
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
|
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
|
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
|
Lispro Low Mix Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|---|---|
|
Initiation
Death
|
1
|
5
|
0
|
0
|
0
|
0
|
|
Initiation
Adverse Event
|
6
|
15
|
0
|
0
|
0
|
0
|
|
Initiation
Lost to Follow-up
|
42
|
41
|
0
|
0
|
0
|
0
|
|
Initiation
Entry Criteria Exclusion
|
7
|
9
|
0
|
0
|
0
|
0
|
|
Initiation
Protocol Violation
|
9
|
10
|
0
|
0
|
0
|
0
|
|
Initiation
Withdrawal by Subject
|
35
|
41
|
0
|
0
|
0
|
0
|
|
Initiation
Physician Decision
|
15
|
18
|
0
|
0
|
0
|
0
|
|
Initiation
Sponsor Decision
|
13
|
5
|
0
|
0
|
0
|
0
|
|
Initiation
Discontinuation Oral Antihyperglycemics
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance
Lack of Efficacy
|
32
|
30
|
0
|
0
|
0
|
0
|
|
Maintenance
Discontinuation Antihyperglycemic Drugs
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Maintenance
Adverse Event
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Maintenance
Death
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Maintenance
Lost to Follow-up
|
17
|
13
|
0
|
0
|
0
|
0
|
|
Maintenance
Entry Criteria Exclusion
|
1
|
4
|
0
|
0
|
0
|
0
|
|
Maintenance
Protocol Violation
|
16
|
24
|
0
|
0
|
0
|
0
|
|
Maintenance
Withdrawal by Subject
|
18
|
18
|
0
|
0
|
0
|
0
|
|
Maintenance
Physician Decision
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Maintenance
Sponsor Decision
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance
HbA1c>7.5%
|
123
|
126
|
0
|
0
|
0
|
0
|
|
Intensification Addendum
Withdrawal by Subject
|
0
|
0
|
12
|
14
|
9
|
18
|
|
Intensification Addendum
Lost to Follow-up
|
0
|
0
|
4
|
6
|
7
|
7
|
|
Intensification Addendum
Protocol Violation
|
0
|
0
|
2
|
2
|
6
|
6
|
|
Intensification Addendum
Adverse Event
|
0
|
0
|
0
|
4
|
1
|
3
|
|
Intensification Addendum
Physician Decision
|
0
|
0
|
4
|
1
|
3
|
2
|
|
Intensification Addendum
Sponsor Decision
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Intensification Addendum
Entry Criteria Exclusion
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Intensification Addendum
Lack of Efficacy
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Intensification Addendum
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Baseline characteristics by cohort
| Measure |
Insulin Glargine
n=1046 Participants
Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
|
Lispro LM
n=1045 Participants
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
|
Total
n=2091 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.59 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
57.05 years
STANDARD_DEVIATION 9.73 • n=7 Participants
|
56.82 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=5 Participants
|
493 Participants
n=7 Participants
|
987 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
552 Participants
n=5 Participants
|
552 Participants
n=7 Participants
|
1104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
668 participants
n=5 Participants
|
651 participants
n=7 Participants
|
1319 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Descent
|
70 participants
n=5 Participants
|
62 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East/Southeast Asian
|
27 participants
n=5 Participants
|
18 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
116 participants
n=5 Participants
|
136 participants
n=7 Participants
|
252 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 participants
n=5 Participants
|
39 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Western Asian
|
136 participants
n=5 Participants
|
139 participants
n=7 Participants
|
275 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
509 participants
n=5 Participants
|
513 participants
n=7 Participants
|
1022 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
98 participants
n=5 Participants
|
95 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
45 participants
n=5 Participants
|
46 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
47 participants
n=5 Participants
|
49 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
India
|
131 participants
n=5 Participants
|
128 participants
n=7 Participants
|
259 participants
n=5 Participants
|
|
Weight
|
88.23 kilograms (kg)
STANDARD_DEVIATION 20.78 • n=5 Participants
|
88.84 kilograms (kg)
STANDARD_DEVIATION 20.97 • n=7 Participants
|
88.53 kilograms (kg)
STANDARD_DEVIATION 20.87 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.69 kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 6.01 • n=5 Participants
|
31.67 kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.96 • n=7 Participants
|
31.68 kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.98 • n=5 Participants
|
|
Duration of Diabetes
|
9.30 years
STANDARD_DEVIATION 5.93 • n=5 Participants
|
9.73 years
STANDARD_DEVIATION 6.29 • n=7 Participants
|
9.51 years
STANDARD_DEVIATION 6.11 • n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
9.02 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.24 • n=5 Participants
|
9.06 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.29 • n=7 Participants
|
9.04 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.26 • n=5 Participants
|
|
1,5 Anhydroglucitol (1,5 AG)
|
4.97 micrograms per milliliter (ug/mL)
STANDARD_DEVIATION 4.06 • n=5 Participants
|
5.02 micrograms per milliliter (ug/mL)
STANDARD_DEVIATION 4.12 • n=7 Participants
|
4.99 micrograms per milliliter (ug/mL)
STANDARD_DEVIATION 4.09 • n=5 Participants
|
|
Mean of Pre-Meals Blood Glucose
|
201.29 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 57.40 • n=5 Participants
|
198.97 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 54.87 • n=7 Participants
|
200.13 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 56.14 • n=5 Participants
|
|
Mean of Post Meals Blood Glucose (Postprandial)
|
241.58 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 61.06 • n=5 Participants
|
240.08 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 58.15 • n=7 Participants
|
240.82 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 59.61 • n=5 Participants
|
|
Average of All Blood Glucose
|
218.05 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 56.55 • n=5 Participants
|
216.12 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 54.40 • n=7 Participants
|
217.08 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 55.48 • n=5 Participants
|
|
Fasting Blood Glucose
|
196.16 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 55.14 • n=5 Participants
|
192.91 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 53.22 • n=7 Participants
|
194.53 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 54.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=990 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=986 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
|
7.33 percent glycosylated hemoglobin
Standard Deviation 1.07
|
7.23 percent glycosylated hemoglobin
Standard Deviation 1.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)Population: Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
HbA1c goal: HbA1c ≤7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c ≤7.0%
Outcome measures
| Measure |
Insulin Glargine
n=418 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=470 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
|
14.40 months
Interval 13.4 to 16.83
|
16.80 months
Interval 14.03 to 19.67
|
—
|
—
|
PRIMARY outcome
Timeframe: Endpoint (Addendum) (24 weeks: Week 48)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
Outcome measures
| Measure |
Insulin Glargine
n=160 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=187 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=159 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=176 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: 24-Week Endpoint HbA1c
|
8.19 percent glycosylated hemoglobin
Standard Deviation 1.26
|
8.03 percent glycosylated hemoglobin
Standard Deviation 1.15
|
8.16 percent glycosylated hemoglobin
Standard Deviation 1.43
|
8.14 percent glycosylated hemoglobin
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline (Initiation) to Endpoint (LOCF, Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=977 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=962 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Change in HbA1c From Baseline to 24 Weeks
|
-1.68 percent glycosylated hemoglobin
Standard Deviation 1.27
|
-1.83 percent glycosylated hemoglobin
Standard Deviation 1.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=990 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=986 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
<=7.0%
|
45.8 percentage of participants
|
52.5 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
<7.0%
|
40.3 percentage of participants
|
47.5 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
<=6.5%
|
22.2 percentage of participants
|
24.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=1030 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1017 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: HbA1c
Baseline (n=1030,1017)
|
9.02 percent glycosylated hemoglobin
Standard Deviation 1.24
|
9.06 percent glycosylated hemoglobin
Standard Deviation 1.29
|
—
|
—
|
|
INITIATION: HbA1c
Week 12 (n=952,953)
|
7.42 percent glycosylated hemoglobin
Standard Deviation 0.95
|
7.27 percent glycosylated hemoglobin
Standard Deviation 0.99
|
—
|
—
|
|
INITIATION: HbA1c
Week 24 (n=922,911)
|
7.28 percent glycosylated hemoglobin
Standard Deviation 1.06
|
7.19 percent glycosylated hemoglobin
Standard Deviation 1.03
|
—
|
—
|
|
INITIATION: HbA1c
Endpoint (LOCF) (n=990,986)
|
7.33 percent glycosylated hemoglobin
Standard Deviation 1.07
|
7.23 percent glycosylated hemoglobin
Standard Deviation 1.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Outcome measures
| Measure |
Insulin Glargine
n=989 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=995 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline mean fasting blood glucose (n=986,993)
|
196.16 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 55.14
|
192.91 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 53.22
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Mean fasting blood glucose (n=938,922)
|
121.52 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 33.41
|
133.54 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 35.00
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline AM 2-hour postprandial BG (n=977,989)
|
251.45 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 64.78
|
252.46 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 64.54
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
AM 2-hour postprandial blood glucose (n=932,920)
|
171.79 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 49.14
|
167.40 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 49.46
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline midday premeal BG (n=976,988)
|
203.87 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 67.31
|
203.76 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 65.93
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Midday 2-hour postprandial BG (n=929,916)
|
169.38 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 46.78
|
167.91 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 48.00
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline evening pre-meal BG (n=983,993)
|
203.33 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 66.50
|
200.36 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 64.56
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Evening pre-meal blood glucose (n=936,922)
|
141.86 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 45.44
|
143.44 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 43.09
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
AM 2-hour blood glucose excursion (n=932,920)
|
50.57 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 43.59
|
34.01 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 45.04
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline PM 2-hour BG excursion (n=979,988)
|
36.50 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 46.11
|
36.31 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 44.37
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
PM 2-hour blood glucose excursion (n=929,921)
|
34.17 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 40.30
|
19.51 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 42.90
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline mean all meal time excursions (n=985,991)
|
40.80 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 29.92
|
41.63 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 28.58
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Mean of all meal time excursions (n=935,921)
|
38.96 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 27.22
|
30.34 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 28.22
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline mean all 2hour PP BG (n=986,993)
|
241.58 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 61.06
|
240.08 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 58.15
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Mean of all 2-hour postprandial BG (n=935,921)
|
172.28 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 41.04
|
166.17 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 39.82
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline AM/PM 2-hour postprandial BG (n=986,993)
|
245.67 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 62.02
|
244.36 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 59.24
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
AM/PM 2-hour postprandial BG (n=935,921)
|
173.73 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 42.83
|
165.19 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 41.71
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline mean all premeal BG (n=988,994)
|
201.29 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 57.40
|
198.97 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 54.87
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Mean of all blood glucose values (n=938,922)
|
149.89 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 34.32
|
147.96 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 32.92
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Mean of all premeal blood glucose (n=938,922)
|
133.62 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 34.09
|
135.80 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 32.80
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Midday premeal blood glucose (BG) (n=934,919)
|
137.43 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 44.05
|
130.36 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 42.44
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline midday 2-hour postprandial BG (n=974,988)
|
232.73 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 68.84
|
231.53 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 66.18
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline evening 2hour postprandial BG (n=983,991)
|
239.73 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 70.28
|
236.33 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 64.92
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Evening 2-hour postprandial BG (n=932,921)
|
175.73 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 48.66
|
163.20 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 46.67
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline 3 AM blood glucose (n=955,975)
|
197.99 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 64.28
|
194.11 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 61.96
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
3 AM blood glucose (n=912,899)
|
131.08 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 42.38
|
129.70 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 40.51
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline AM 2-hour BG excursion (n=975,987)
|
55.32 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 46.93
|
60.06 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 47.21
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline midday 2-hour BG excursion (n=966,981)
|
26.60 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 48.50
|
28.08 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 45.09
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Midday 2-hour blood glucose excursion (n=928,916)
|
32.21 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 40.40
|
37.46 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 44.40
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline AM/PM 2-hour BG excursion (n=985,991)
|
46.05 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 35.06
|
48.11 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 35.77
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
AM/PM 2-hour blood glucose excursion (n=935,921)
|
42.42 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 31.96
|
26.74 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 34.01
|
—
|
—
|
|
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Baseline mean of all BG values (n=989,995)
|
218.05 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 56.55
|
216.12 milligrams per 100 Milliliters (mg/dL)
Standard Deviation 54.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Initiation), Endpoint (Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=942 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=925 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
|
4.61 micrograms per milliliter (ug/mL)
Standard Deviation 4.85
|
5.25 micrograms per milliliter (ug/mL)
Standard Deviation 4.85
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=1016 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1008 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Incremental Change From Baseline in Body Weight
Change from baseline at Week 6 (n=1008,995)
|
0.97 kilograms (kg)
Standard Deviation 2.48
|
1.66 kilograms (kg)
Standard Deviation 2.29
|
—
|
—
|
|
INITIATION: Incremental Change From Baseline in Body Weight
Change from baseline at Week 12 (n=970, 960)
|
1.60 kilograms (kg)
Standard Deviation 3.41
|
2.63 kilograms (kg)
Standard Deviation 3.16
|
—
|
—
|
|
INITIATION: Incremental Change From Baseline in Body Weight
Change from baseline at Week 18 (n=943,927)
|
2.24 kilograms (kg)
Standard Deviation 3.65
|
3.44 kilograms (kg)
Standard Deviation 3.65
|
—
|
—
|
|
INITIATION: Incremental Change From Baseline in Body Weight
Change from baseline at Week 24 (n=925,911)
|
2.59 kilograms (kg)
Standard Deviation 4.09
|
3.76 kilograms (kg)
Standard Deviation 4.00
|
—
|
—
|
|
INITIATION: Incremental Change From Baseline in Body Weight
Change from baseline at endpoint (n=1016,1008)
|
2.45 kilograms (kg)
Standard Deviation 4.02
|
3.60 kilograms (kg)
Standard Deviation 3.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=1046 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1044 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Body Weight
Actual weight at Week 6 (n=1008,995)
|
89.24 kilograms
Standard Deviation 20.88
|
90.63 kilograms
Standard Deviation 20.94
|
—
|
—
|
|
INITIATION: Body Weight
Actual weight at Week 12 (n=970,960)
|
89.80 kilograms
Standard Deviation 20.96
|
91.79 kilograms
Standard Deviation 21.16
|
—
|
—
|
|
INITIATION: Body Weight
Actual weight at Week 18 (n=943,927)
|
90.33 kilograms
Standard Deviation 21.17
|
92.46 kilograms
Standard Deviation 21.27
|
—
|
—
|
|
INITIATION: Body Weight
Actual weight at Baseline (n=1046,1044)
|
88.23 kilograms
Standard Deviation 20.78
|
88.84 kilograms
Standard Deviation 20.97
|
—
|
—
|
|
INITIATION: Body Weight
Actual weight at Week 24 (n=925,911)
|
90.78 kilograms
Standard Deviation 21.46
|
92.63 kilograms
Standard Deviation 21.23
|
—
|
—
|
|
INITIATION: Body Weight
Actual weight Endpoint (n=1016,1008)
|
90.74 kilograms
Standard Deviation 21.36
|
92.67 kilograms
Standard Deviation 21.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=1024 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1026 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemic episodes endpoint
|
51.8 percentage of participants
|
57.1 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Overall hypoglycemic episodes
|
76.7 percentage of participants
|
80.5 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal hypoglycemic episodes endpoint
|
34.3 percentage of participants
|
33.9 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal hypoglycemic episodes overall
|
58.4 percentage of participants
|
59.6 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe hypoglycemic episodes endpoint
|
0.2 percentage of participants
|
0.6 percentage of participants
|
—
|
—
|
|
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe hypoglycemic episodes overall
|
1.2 percentage of participants
|
2.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=1024 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1026 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Endpoint
|
11.42 Episodes/participant/year
Standard Deviation 25.31
|
8.86 Episodes/participant/year
Standard Deviation 19.27
|
—
|
—
|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Endpoint
|
0.02 Episodes/participant/year
Standard Deviation 0.38
|
0.09 Episodes/participant/year
Standard Deviation 0.10
|
—
|
—
|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Overall
|
0.03 Episodes/participant/year
Standard Deviation 0.31
|
0.10 Episodes/participant/year
Standard Deviation 1.61
|
—
|
—
|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Overall
|
9.80 Episodes/participant/year
Standard Deviation 17.50
|
9.22 Episodes/participant/year
Standard Deviation 16.66
|
—
|
—
|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Endpoint
|
20.28 Episodes/participant/year
Standard Deviation 38.25
|
24.96 Episodes/participant/year
Standard Deviation 39.45
|
—
|
—
|
|
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Overall
|
18.14 Episodes/participant/year
Standard Deviation 28.05
|
25.49 Episodes/participant/year
Standard Deviation 36.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Outcome measures
| Measure |
Insulin Glargine
n=1029 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=1036 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Insulin Dose
Week 18 (n=943,943)
|
0.39 units/kg/day
Standard Deviation 0.22
|
0.46 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 24 (n=915,920)
|
0.41 units/kg/day
Standard Deviation 0.23
|
0.48 units/kg/day
Standard Deviation 0.23
|
—
|
—
|
|
INITIATION: Insulin Dose
Endpoint (n=1029,1036)
|
0.40 units/kg/day
Standard Deviation 0.23
|
0.47 units/kg/day
Standard Deviation 0.23
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 1 (n=994,1001)
|
0.13 units/kg/day
Standard Deviation 0.04
|
0.24 units/kg/day
Standard Deviation 0.07
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 2 (n=991, 987)
|
0.18 units/kg/day
Standard Deviation 0.07
|
0.28 units/kg/day
Standard Deviation 0.09
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 3 (n=990,968)
|
0.23 units/kg/day
Standard Deviation 0.09
|
0.32 units/kg/day
Standard Deviation 0.10
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 4 (n=971,958)
|
0.26 units/kg/day
Standard Deviation 0.11
|
0.35 units/kg/day
Standard Deviation 0.12
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 5 (n=958,930)
|
0.30 units/kg/day
Standard Deviation 0.14
|
0.38 units/kg/day
Standard Deviation 0.14
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 6 (n=998,1023)
|
0.32 units/kg/day
Standard Deviation 0.15
|
0.39 units/kg/day
Standard Deviation 0.15
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 8 (n=949,933)
|
0.34 units/kg/day
Standard Deviation 0.17
|
0.42 units/kg/day
Standard Deviation 0.17
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 10 (n=925,916)
|
0.37 units/kg/day
Standard Deviation 0.19
|
0.44 units/kg/day
Standard Deviation 0.18
|
—
|
—
|
|
INITIATION: Insulin Dose
Week 12 (n=970,972)
|
0.38 units/kg/day
Standard Deviation 0.20
|
0.45 units/kg/day
Standard Deviation 0.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=927 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=906 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
|
58.21 years
Standard Deviation 9.31
|
55.85 years
Standard Deviation 9.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=927 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=906 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Hispanic
|
96 participants
|
102 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Other
|
20 participants
|
36 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Caucasian
|
680 participants
|
521 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
East/Southeast Asian
|
11 participants
|
28 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
African Descent
|
50 participants
|
44 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Western Asian
|
70 participants
|
175 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) \* fasting plasma glucose (millimoles per liter) / 22.5.
Outcome measures
| Measure |
Insulin Glargine
n=877 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=859 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
4.44 units on a scale
Standard Deviation 3.73
|
5.45 units on a scale
Standard Deviation 5.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=915 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=885 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
|
8.66 percent glycosylated hemoglobin
Standard Deviation 1.13
|
9.40 percent glycosylated hemoglobin
Standard Deviation 1.25
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of baseline HbA1c percentage group (\<8.5,\>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=915 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=885 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
<8.5% HbA1c
|
464 participants
|
220 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
>=8.5% HbA1c
|
451 participants
|
665 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=916 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=889 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
|
5.74 micrograms per milliliter (ug/mL)
Standard Deviation 4.37
|
4.28 micrograms per milliliter (ug/mL)
Standard Deviation 3.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=894 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=866 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Post Meals Blood Glucose (n=891,865)
|
228.87 milligrams per deciliter (mg/dL)
Standard Deviation 54.58
|
252.90 milligrams per deciliter (mg/dL)
Standard Deviation 60.85
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Average of All Blood Glucose (n=894,866)
|
206.43 milligrams per deciliter (mg/dL)
Standard Deviation 50.05
|
227.77 milligrams per deciliter (mg/dL)
Standard Deviation 57.04
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Pre Meals Blood Glucose (n=892,866)
|
190.47 milligrams per deciliter (mg/dL)
Standard Deviation 49.67
|
209.86 milligrams per deciliter (mg/dL)
Standard Deviation 59.08
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Fasting Blood Glucose (n=891,864)
|
189.04 milligrams per deciliter (mg/dL)
Standard Deviation 48.73
|
201.22 milligrams per deciliter (mg/dL)
Standard Deviation 57.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (Initiation: Week 24)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Outcome measures
| Measure |
Insulin Glargine
n=917 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=901 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Sulfonylurea/TZD
|
51 participants
|
51 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Patients with 3 drugs (Sulfonylurea/TZD/Metformin)
|
208 participants
|
184 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Sulfonylurea/Metformin
|
563 participants
|
631 participants
|
—
|
—
|
|
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
TZD/Metformin
|
95 participants
|
35 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=418 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=471 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 36 (n=403,460)
|
6.72 percent glycosylated hemoglobin
Standard Deviation 0.60
|
6.71 percent glycosylated hemoglobin
Standard Deviation 0.61
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Endpoint (n=414,470)
|
7.20 percent glycosylated hemoglobin
Standard Deviation 0.82
|
7.10 percent glycosylated hemoglobin
Standard Deviation 0.81
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 0 (n=415,464)
|
8.59 percent glycosylated hemoglobin
Standard Deviation 1.08
|
8.69 percent glycosylated hemoglobin
Standard Deviation 1.16
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 12 (n=412,465)
|
6.82 percent glycosylated hemoglobin
Standard Deviation 0.56
|
6.75 percent glycosylated hemoglobin
Standard Deviation 1.16
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 24 (n=418,471)
|
6.49 percent glycosylated hemoglobin
Standard Deviation 0.40
|
6.49 percent glycosylated hemoglobin
Standard Deviation 0.42
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 48 (n=395,443)
|
6.85 percent glycosylated hemoglobin
Standard Deviation 0.70
|
6.80 percent glycosylated hemoglobin
Standard Deviation 0.70
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 60 (n=332,403)
|
6.85 percent glycosylated hemoglobin
Standard Deviation 0.63
|
6.83 percent glycosylated hemoglobin
Standard Deviation 0.63
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 72 (n=305,363)
|
6.80 percent glycosylated hemoglobin
Standard Deviation 0.68
|
6.79 percent glycosylated hemoglobin
Standard Deviation 0.66
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 84 (n=268,312)
|
6.79 percent glycosylated hemoglobin
Standard Deviation 0.60
|
6.74 percent glycosylated hemoglobin
Standard Deviation 0.60
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 96 (n=242,291)
|
6.85 percent glycosylated hemoglobin
Standard Deviation 0.64
|
6.73 percent glycosylated hemoglobin
Standard Deviation 0.60
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 108 (n=219,257)
|
6.83 percent glycosylated hemoglobin
Standard Deviation 0.63
|
6.72 percent glycosylated hemoglobin
Standard Deviation 0.56
|
—
|
—
|
|
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Week 120 (n=204,240)
|
6.87 percent glycosylated hemoglobin
Standard Deviation 0.65
|
6.75 percent glycosylated hemoglobin
Standard Deviation 0.60
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Outcome measures
| Measure |
Insulin Glargine
n=405 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=457 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline mean fasting blood glucose (n=403,456)
|
190.90 mg/dL
Standard Deviation 48.90
|
187.12 mg/dL
Standard Deviation 48.16
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint mean fasting blood glucose (n=372,426)
|
119.50 mg/dL
Standard Deviation 29.04
|
127.92 mg/dL
Standard Deviation 32.90
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline AM 2-hour (hr) postprandial (n=398,455)
|
243.62 mg/dL
Standard Deviation 58.58
|
243.55 mg/dL
Standard Deviation 61.38
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint midday premeal blood glucose (n=370,425)
|
132.25 mg/dL
Standard Deviation 38.28
|
126.42 mg/dL
Standard Deviation 37.84
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint midday 2hr postprandial (n=370,424)
|
159.81 mg/dL
Standard Deviation 42.21
|
158.58 mg/dL
Standard Deviation 40.00
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline PM pre-meal blood glucose (n=402,455)
|
190.06 mg/dL
Standard Deviation 57.83
|
187.92 mg/dL
Standard Deviation 56.68
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline 3AM blood glucose (n=393,450)
|
189.36 mg/dL
Standard Deviation 59.87
|
183.18 mg/dL
Standard Deviation 57.15
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint 3AM blood glucose (n=363,419)
|
126.05 mg/dL
Standard Deviation 34.33
|
123.43 mg/dL
Standard Deviation 35.37
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline AM 2hr excursion (n=397,455)
|
52.63 mg/dL
Standard Deviation 44.06
|
56.96 mg/dL
Standard Deviation 45.40
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint AM 2hr excursion (n=368,426)
|
45.69 mg/dL
Standard Deviation 39.41
|
33.61 mg/dL
Standard Deviation 38.67
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline midday 2hr excursion (n=395,452)
|
25.13 mg/dL
Standard Deviation 46.67
|
27.02 mg/dL
Standard Deviation 43.17
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint midday 2hr excursion (n=370,423)
|
27.78 mg/dL
Standard Deviation 37.38
|
32.03 mg/dL
Standard Deviation 38.64
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline combined AM/PM 2hr postprandial (402,457)
|
233.82 mg/dL
Standard Deviation 55.31
|
233.25 mg/dL
Standard Deviation 55.06
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint AM/PM 2hr postprandial excursion (370,426
|
40.76 mg/dL
Standard Deviation 32.01
|
28.69 mg/dL
Standard Deviation 31.08
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline mean all blood glucose values (n=405,457)
|
207.01 mg/dL
Standard Deviation 49.91
|
205.17 mg/dL
Standard Deviation 48.86
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint AM 2-hour postprandial (n=368,426)
|
164.94 mg/dL
Standard Deviation 44.29
|
161.37 mg/dL
Standard Deviation 44.66
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline midday premeal blood glucose (n=400,454)
|
193.21 mg/dL
Standard Deviation 61.66
|
192.02 mg/dL
Standard Deviation 60.21
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline midday 2hr postprandial (n=397,456)
|
217.67 mg/dL
Standard Deviation 61.90
|
218.54 mg/dL
Standard Deviation 60.65
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint PM pre-meal blood glucose (n=371,425)
|
131.58 mg/dL
Standard Deviation 37.22
|
133.15 mg/dL
Standard Deviation 37.30
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline PM 2hr postprandial (n=399,455)
|
223.83 mg/dL
Standard Deviation 62.70
|
223.02 mg/dL
Standard Deviation 60.64
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint PM 2hr postprandial (n=369,425)
|
167.66 mg/dL
Standard Deviation 43.81
|
156.48 mg/dL
Standard Deviation 44.10
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline PM 2hr excursion (n=398,453)
|
33.87 mg/dL
Standard Deviation 42.37
|
34.78 mg/dL
Standard Deviation 44.40
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint PM 2hr excursion (n=369,424)
|
36.24 mg/dL
Standard Deviation 37.55
|
23.45 mg/dL
Standard Deviation 41.99
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline mean all meal time excursions (n=402,455)
|
37.36 mg/dL
Standard Deviation 27.26
|
39.65 mg/dL
Standard Deviation 25.60
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint mean all meal time excursions (n=370,426)
|
36.32 mg/dL
Standard Deviation 26.25
|
29.81 mg/dL
Standard Deviation 27.04
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline mean of all 2hr postprandial (n=402,457)
|
228.52 mg/dL
Standard Deviation 54.01
|
228.39 mg/dL
Standard Deviation 53.63
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint mean of all 2hr postprandial (n=370,426)
|
164.17 mg/dL
Standard Deviation 36.30
|
158.91 mg/dL
Standard Deviation 36.07
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline mean all premeal (n=404,456)
|
191.46 mg/dL
Standard Deviation 50.02
|
188.95 mg/dL
Standard Deviation 48.34
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint mean all premeal (n=372,426)
|
127.61 mg/dL
Standard Deviation 28.40
|
129.16 mg/dL
Standard Deviation 29.41
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint combined AM/PM 2hr postprandial (370,426)
|
166.34 mg/dL
Standard Deviation 38.28
|
158.97 mg/dL
Standard Deviation 38.59
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Baseline AM/PM 2hr postprandial excursion (402,455
|
43.46 mg/dL
Standard Deviation 32.72
|
45.80 mg/dL
Standard Deviation 33.80
|
—
|
—
|
|
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Endpoint mean all blood glucose values (n=372,426)
|
142.94 mg/dL
Standard Deviation 29.16
|
141.01 mg/dL
Standard Deviation 28.97
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance: up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Rate of increase: HbA1c change/time period (month).
Outcome measures
| Measure |
Insulin Glargine
n=412 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=469 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Rate of Increase in HbA1c
|
0.06 HbA1c percent increase per month
Standard Deviation 0.08
|
0.05 HbA1c percent increase per month
Standard Deviation 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance: up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=414 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=470 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
<=6.5%
|
23.7 percentage of participants
|
26.4 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
<=7.0%
|
44.9 percentage of participants
|
49.1 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
<7.0%
|
40.1 percentage of participants
|
45.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=419 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=473 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Baseline (n=419,473)
|
90.56 kilograms
Standard Deviation 20.12
|
88.62 kilograms
Standard Deviation 19.05
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 24 (n=417,470)
|
2.05 kilograms
Standard Deviation 3.79
|
3.68 kilograms
Standard Deviation 3.89
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 36 (n=411,465)
|
2.71 kilograms
Standard Deviation 4.22
|
4.56 kilograms
Standard Deviation 4.44
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 48 (n=399,460)
|
3.08 kilograms
Standard Deviation 4.46
|
4.82 kilograms
Standard Deviation 4.81
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 60 (n=362,414)
|
3.33 kilograms
Standard Deviation 4.76
|
5.13 kilograms
Standard Deviation 5.22
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 72 (n=315,372)
|
3.12 kilograms
Standard Deviation 5.15
|
5.40 kilograms
Standard Deviation 5.72
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 84 (n=281,327)
|
3.16 kilograms
Standard Deviation 5.20
|
5.84 kilograms
Standard Deviation 5.87
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 96 (n=248,297)
|
3.11 kilograms
Standard Deviation 5.35
|
5.60 kilograms
Standard Deviation 5.68
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 108 (n=228,268)
|
3.48 kilograms
Standard Deviation 5.65
|
5.57 kilograms
Standard Deviation 5.66
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Week 120 (n=204,253)
|
3.71 kilograms
Standard Deviation 5.47
|
5.48 kilograms
Standard Deviation 5.88
|
—
|
—
|
|
MAINTENANCE: Incremental Change From Baseline in Body Weight
Change from baseline at Endpoint (n=414,470)
|
3.65 kilograms
Standard Deviation 5.60
|
5.40 kilograms
Standard Deviation 5.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=419 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=473 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Body Weight
Week 60 (n=362,414)
|
93.17 kilograms
Standard Deviation 20.60
|
94.57 kilograms
Standard Deviation 19.62
|
—
|
—
|
|
MAINTENANCE: Body Weight
Baseline (n=419,473)
|
90.56 kilograms
Standard Deviation 20.12
|
88.62 kilograms
Standard Deviation 19.05
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 24 (n=417, 470)
|
92.64 kilograms
Standard Deviation 20.53
|
92.35 kilograms
Standard Deviation 19.10
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 36 (n=411, 465)
|
93.13 kilograms
Standard Deviation 20.68
|
93.24 kilograms
Standard Deviation 19.38
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 48 (n=399,460)
|
93.23 kilograms
Standard Deviation 20.53
|
93.57 kilograms
Standard Deviation 19.41
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 72 (n=315,372)
|
93.62 kilograms
Standard Deviation 20.40
|
95.50 kilograms
Standard Deviation 19.63
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 84 (n=281,327)
|
93.46 kilograms
Standard Deviation 20.56
|
95.63 kilograms
Standard Deviation 19.78
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 96 (n=248, 297)
|
93.33 kilograms
Standard Deviation 20.14
|
95.34 kilograms
Standard Deviation 19.50
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 108 (n=228,268)
|
93.39 kilograms
Standard Deviation 20.23
|
95.07 kilograms
Standard Deviation 19.61
|
—
|
—
|
|
MAINTENANCE: Body Weight
Week 120 (n=204,253)
|
93.99 kilograms
Standard Deviation 20.22
|
94.82 kilograms
Standard Deviation 19.62
|
—
|
—
|
|
MAINTENANCE: Body Weight
Endpoint (n=414,470)
|
94.14 kilograms
Standard Deviation 21.04
|
94.01 kilograms
Standard Deviation 19.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=418 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=473 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Insulin Dose
Week 120 (n=205,254)
|
0.36 units/kg/day
Standard Deviation 0.20
|
0.44 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Endpoint (n=416,472)
|
0.37 units/kg/day
Standard Deviation 0.21
|
0.45 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 24 (n=418,473)
|
0.36 units/kg/day
Standard Deviation 0.19
|
0.43 units/kg/day
Standard Deviation 0.19
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 36 (n=415,470)
|
0.36 units/kg/day
Standard Deviation 0.19
|
0.44 units/kg/day
Standard Deviation 0.20
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 48 (n=407,464)
|
0.37 units/kg/day
Standard Deviation 0.20
|
0.44 units/kg/day
Standard Deviation 0.20
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 60 (n=364,419)
|
0.37 units/kg/day
Standard Deviation 0.19
|
0.44 units/kg/day
Standard Deviation 0.19
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 72 (n=317,374)
|
0.37 units/kg/day
Standard Deviation 0.20
|
0.44 units/kg/day
Standard Deviation 0.20
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 84 (n=284,334)
|
0.36 units/kg/day
Standard Deviation 0.20
|
0.44 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 96 (n=251,303)
|
0.37 units/kg/day
Standard Deviation 0.21
|
0.44 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
|
MAINTENANCE: Insulin Dose
Week 108 (n=233,273)
|
0.36 units/kg/day
Standard Deviation 0.20
|
0.43 units/kg/day
Standard Deviation 0.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=419 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=473 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Overall hypoglycemic episodes (n=419,473)
|
94.0 percentage of participants
|
97.9 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe episodes endpoint (n=415,471)
|
0.5 percentage of participants
|
0.6 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe episodes overall (n=419,473)
|
2.9 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Overall hypoglycemic episodes endpoint (n=415,471)
|
45.3 percentage of participants
|
49.9 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal episodes endpoint (n=415,471)
|
30.4 percentage of participants
|
28.9 percentage of participants
|
—
|
—
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal episodes overall (n=419,473)
|
81.1 percentage of participants
|
84.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=415 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=471 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Endpoint
|
16.41 episodes/participant/year
Standard Deviation 34.78
|
18.56 episodes/participant/year
Standard Deviation 35.50
|
—
|
—
|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Overall
|
21.80 episodes/participant/year
Standard Deviation 26.77
|
26.08 episodes/participant/year
Standard Deviation 31.69
|
—
|
—
|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Endpoint
|
7.70 episodes/participant/year
Standard Deviation 19.36
|
5.86 episodes/participant/year
Standard Deviation 15.96
|
—
|
—
|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Overall
|
9.77 episodes/participant/year
Standard Deviation 15.01
|
8.02 episodes/participant/year
Standard Deviation 13.49
|
—
|
—
|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Endpoint
|
0.23 episodes/participant/year
Standard Deviation 4.43
|
0.03 episodes/participant/year
Standard Deviation 0.46
|
—
|
—
|
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Overall
|
0.12 episodes/participant/year
Standard Deviation 2.12
|
0.03 episodes/participant/year
Standard Deviation 0.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=372 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=428 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Baseline
|
5.66 ug/dL
Standard Deviation 4.34
|
5.87 ug/dL
Standard Deviation 4.51
|
—
|
—
|
|
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Endpoint
|
10.48 ug/dL
Standard Deviation 6.26
|
11.71 ug/dL
Standard Deviation 6.44
|
—
|
—
|
|
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Change
|
4.82 ug/dL
Standard Deviation 5.28
|
5.84 ug/dL
Standard Deviation 5.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=415 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=469 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Baseline at Week 0 (n=415,464)
|
8.59 percent glycosylated hemoglobin
Standard Deviation 1.08
|
8.69 percent glycosylated hemoglobin
Standard Deviation 1.16
|
—
|
—
|
|
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Change from baseline to endpoint (n=409,462)
|
-1.38 percent glycosylated hemoglobin
Standard Deviation 1.18
|
-1.59 percent glycosylated hemoglobin
Standard Deviation 1.22
|
—
|
—
|
|
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Change Week 24 to Week 120 endpoint (n=412,469)
|
0.71 percent glycosylated hemoglobin
Standard Deviation 0.11
|
0.61 percent glycosylated hemoglobin
Standard Deviation 0.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=147 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=272 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
|
8.44 years
Standard Deviation 4.92
|
9.70 years
Standard Deviation 6.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=202 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=271 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
|
9.42 years
Standard Deviation 6.24
|
9.87 years
Standard Deviation 6.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=147 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=272 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
10 years to less than 20 years
|
45 participants
|
94 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
20 or more years
|
6 participants
|
26 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Less than 10 years
|
96 participants
|
152 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=202 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=271 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
<10 years
|
112 participants
|
148 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
10 to <20 years
|
78 participants
|
97 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
>=20 years
|
12 participants
|
26 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=143 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=270 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
|
8.27 percent glycosylated hemoglobin
Standard Deviation 0.94
|
8.77 percent glycosylated hemoglobin
Standard Deviation 1.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=198 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=268 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
|
8.54 percent glycosylated hemoglobin
Standard Deviation 1.13
|
8.80 percent glycosylated hemoglobin
Standard Deviation 1.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=143 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=270 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Less than 8.5% HbA1c
|
97 participants
|
121 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
>=8.5% HbA1c
|
46 participants
|
149 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=198 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=268 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Less than 8.5
|
110 participants
|
121 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
8.5 or more
|
88 participants
|
147 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=144 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=269 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/TZD
|
16 participants
|
13 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/metformin
|
73 participants
|
175 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Metformin/TZD
|
22 participants
|
22 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/metformin/TZD
|
33 participants
|
59 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=199 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=270 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/TZD
|
14 participants
|
5 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/metformin
|
115 participants
|
185 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Metformin/TZD
|
25 participants
|
21 participants
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Sulfonylurea/metformin/TZD
|
45 participants
|
59 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=146 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=271 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
|
6.29 ug/mL
Standard Deviation 4.60
|
5.39 ug/mL
Standard Deviation 4.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=199 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=265 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
|
5.93 ug/ml
Standard Deviation 4.17
|
5.73 ug/ml
Standard Deviation 4.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=141 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=264 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Mean of post meals blood glucose (n=141,261)
|
219.28 mg/dL
Standard Deviation 51.23
|
233.51 mg/dL
Standard Deviation 54.90
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Average of all blood glucose (n=141,264)
|
200.60 mg/dL
Standard Deviation 48.07
|
210.44 mg/dL
Standard Deviation 50.63
|
—
|
—
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) (Maintenance) (up to 2.5 years)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Outcome measures
| Measure |
Insulin Glargine
n=195 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=262 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Mean of post meals blood glucose
|
223.98 mg/dL
Standard Deviation 52.54
|
231.66 mg/dL
Standard Deviation 54.30
|
—
|
—
|
|
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Average of all blood glucose
|
201.42 mg/dL
Standard Deviation 48.42
|
207.96 mg/dL
Standard Deviation 49.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=174 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=200 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=171 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=199 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Baseline (n=174,200,171,199)
|
8.01 percent
Standard Deviation 0.93
|
8.03 percent
Standard Deviation 0.95
|
8.00 percent
Standard Deviation 0.92
|
7.98 percent
Standard Deviation 0.95
|
|
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Endpoint (n=160,187,159,176)
|
0.19 percent
Standard Deviation 1.12
|
0.04 percent
Standard Deviation 1.06
|
0.19 percent
Standard Deviation 1.16
|
0.18 percent
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Endpoint (Addendum: 24 weeks [Week 48])Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=176 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=187 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=159 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=176 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
<=7.0%
|
12.5 percent of participants
|
16.0 percent of participants
|
22.0 percent of participants
|
18.2 percent of participants
|
|
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
<7.0%
|
8.8 percent of participants
|
13.9 percent of participants
|
17.6 percent of participants
|
4.0 percent of participants
|
|
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
<=6.5%
|
4.4 percent of participants
|
3.7 percent of participants
|
5.0 percent of participants
|
4.0 percent of participants
|
SECONDARY outcome
Timeframe: Endpoint (Addendum: 24 weeks [Week 48])Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Outcome measures
| Measure |
Insulin Glargine
n=152 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=161 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=183 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=187 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: 7-point SMPG Profiles
Mean fast blood glucose (BG) (n=135,150,161,178)
|
145.33 mg/dL
Standard Deviation 35.23
|
151.15 mg/dL
Standard Deviation 37.31
|
126.22 mg/dL
Standard Deviation 39.00
|
139.45 mg/dL
Standard Deviation 34.92
|
|
ADDENDUM: 7-point SMPG Profiles
AM 2-hour postprandial (PP) BG (n=135,149,160,176)
|
168.71 mg/dL
Standard Deviation 44.90
|
170.36 mg/dL
Standard Deviation 50.25
|
170.14 mg/dL
Standard Deviation 49.27
|
171.40 mg/dL
Standard Deviation 46.90
|
|
ADDENDUM: 7-point SMPG Profiles
Midday premeal blood glucose (n=135,150,161,177)
|
144.08 mg/dL
Standard Deviation 43.93
|
145.89 mg/dL
Standard Deviation 42.61
|
144.61 mg/dL
Standard Deviation 41.39
|
141.87 mg/dL
Standard Deviation 43.33
|
|
ADDENDUM: 7-point SMPG Profiles
Midday 2-hour (hr) PP BG (n=135,149,160,176))
|
165.24 mg/dL
Standard Deviation 46.46
|
164.13 mg/dL
Standard Deviation 42.17
|
167.45 mg/dL
Standard Deviation 48.27
|
181.46 mg/dL
Standard Deviation 53.34
|
|
ADDENDUM: 7-point SMPG Profiles
PM premeal blood glucose (n=135,150,161,178)
|
153.62 mg/dL
Standard Deviation 41.82
|
151.96 mg/dL
Standard Deviation 41.66
|
157.15 mg/dL
Standard Deviation 54.22
|
153.19 mg/dL
Standard Deviation 40.74
|
|
ADDENDUM: 7-point SMPG Profiles
PM 2-hour postprandial BG (n=134,150,161,178)
|
171.51 mg/dL
Standard Deviation 44.42
|
172.98 mg/dL
Standard Deviation 48.01
|
175.34 mg/dL
Standard Deviation 53.17
|
174.94 mg/dL
Standard Deviation 46.73
|
|
ADDENDUM: 7-point SMPG Profiles
3 AM blood glucose (n=132,146,153,171)
|
146.50 mg/dL
Standard Deviation 40.09
|
146.30 mg/dL
Standard Deviation 41.36
|
147.14 mg/dL
Standard Deviation 39.99
|
139.86 mg/dL
Standard Deviation 39.15
|
|
ADDENDUM: 7-point SMPG Profiles
AM 2-hour BG excursion (n=135,149,160,176)
|
23.30 mg/dL
Standard Deviation 39.14
|
18.97 mg/dL
Standard Deviation 46.88
|
24.35 mg/dL
Standard Deviation 38.44
|
31.33 mg/dL
Standard Deviation 43.27
|
|
ADDENDUM: 7-point SMPG Profiles
Midday 2-hour BG excursion (n=135,148,160,176)
|
20.71 mg/dL
Standard Deviation 43.35
|
18.97 mg/dL
Standard Deviation 41.40
|
23.30 mg/dL
Standard Deviation 37.21
|
39.40 mg/dL
Standard Deviation 46.21
|
|
ADDENDUM: 7-point SMPG Profiles
PM 2-hour BG excursion (n=134,150,161,178)
|
17.88 mg/dL
Standard Deviation 38.16
|
21.14 mg/dL
Standard Deviation 42.48
|
18.58 mg/dL
Standard Deviation 41.86
|
21.59 mg/dL
Standard Deviation 43.88
|
|
ADDENDUM: 7-point SMPG Profiles
Mean all mealtime excursions (n=135,150,161,178)
|
20.61 mg/dL
Standard Deviation 28.41
|
19.64 mg/dL
Standard Deviation 27.87
|
21.82 mg/dL
Standard Deviation 26.09
|
30.38 mg/dL
Standard Deviation 31.11
|
|
ADDENDUM: 7-point SMPG Profiles
Mean all 2-hour PP BG (n=135,150,161,178)
|
168.55 mg/dL
Standard Deviation 38.92
|
169.14 mg/dL
Standard Deviation 39.27
|
170.95 mg/dL
Standard Deviation 42.89
|
175.61 mg/dL
Standard Deviation 42.15
|
|
ADDENDUM: 7-point SMPG Profiles
Mean all premeal blood glucose (n=135,150,161,178)
|
147.68 mg/dL
Standard Deviation 32.85
|
149.67 mg/dL
Standard Deviation 33.20
|
149.04 mg/dL
Standard Deviation 38.35
|
144.85 mg/dL
Standard Deviation 32.07
|
|
ADDENDUM: 7-point SMPG Profiles
Mean combined AM/PM 2hr PP BG (n=135,150,161,178)
|
170.04 mg/dL
Standard Deviation 39.98
|
171.65 mg/dL
Standard Deviation 43.23
|
172.73 mg/dL
Standard Deviation 45.15
|
172.88 mg/dL
Standard Deviation 41.56
|
|
ADDENDUM: 7-point SMPG Profiles
Mean AM/PM 2hr BG excursion (n=135,150,161,178)
|
20.74 mg/dL
Standard Deviation 30.40
|
20.06 mg/dL
Standard Deviation 34.62
|
21.42 mg/dL
Standard Deviation 32.09
|
26.45 mg/dL
Standard Deviation 33.36
|
|
ADDENDUM: 7-point SMPG Profiles
Mean all BG values (n=135,150,161,178)
|
156.41 mg/dL
Standard Deviation 33.04
|
157.52 mg/dL
Standard Deviation 32.67
|
158.33 mg/dL
Standard Deviation 37.89
|
157.41 mg/dL
Standard Deviation 33.21
|
|
ADDENDUM: 7-point SMPG Profiles
Baseline mean all premeals BG (n=152,161,183,187)
|
149.91 mg/dL
Standard Deviation 38.96
|
149.50 mg/dL
Standard Deviation 34.82
|
146.64 mg/dL
Standard Deviation 39.89
|
146.01 mg/dL
Standard Deviation 34.80
|
|
ADDENDUM: 7-point SMPG Profiles
Baseline mean of postmeal BG (n=152,161,182,187)
|
183.82 mg/dL
Standard Deviation 45.13
|
181.18 mg/dL
Standard Deviation 43.49
|
186.19 mg/dL
Standard Deviation 46.23
|
185.62 mg/dL
Standard Deviation 41.67
|
|
ADDENDUM: 7-point SMPG Profiles
Baseline average of all BG (n=152,161,183,187)
|
164.02 mg/dL
Standard Deviation 39.20
|
162.18 mg/dL
Standard Deviation 35.22
|
163.19 mg/dL
Standard Deviation 40.08
|
163.20 mg/dL
Standard Deviation 34.69
|
|
ADDENDUM: 7-point SMPG Profiles
Baseline fasting glucose (n=152,161,183,187)
|
147.93 mg/dL
Standard Deviation 39.46
|
143.99 mg/dL
Standard Deviation 34.91
|
131.54 mg/dL
Standard Deviation 42.16
|
131.02 mg/dL
Standard Deviation 34.91
|
SECONDARY outcome
Timeframe: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=170 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=173 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=198 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=200 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Incremental Change From Baseline in Body Weight
Baseline (n=170,173,198,200)
|
91.85 kilograms
Standard Deviation 23.41
|
93.63 kilograms
Standard Deviation 24.21
|
89.25 kilograms
Standard Deviation 21.62
|
90.09 kilograms
Standard Deviation 23.45
|
|
ADDENDUM: Incremental Change From Baseline in Body Weight
Week 6 change (n=161,162,183,193)
|
0.38 kilograms
Standard Deviation 2.78
|
0.28 kilograms
Standard Deviation 1.76
|
0.32 kilograms
Standard Deviation 2.15
|
0.64 kilograms
Standard Deviation 2.10
|
|
ADDENDUM: Incremental Change From Baseline in Body Weight
Week 24 change (n=144,151,163,176)
|
0.77 kilograms
Standard Deviation 3.01
|
0.73 kilograms
Standard Deviation 2.85
|
1.03 kilograms
Standard Deviation 3.24
|
1.51 kilograms
Standard Deviation 3.11
|
|
ADDENDUM: Incremental Change From Baseline in Body Weight
Endpoint change (n=163,169,191,198)
|
0.85 kilograms
Standard Deviation 3.46
|
0.55 kilograms
Standard Deviation 2.85
|
0.86 kilograms
Standard Deviation 3.41
|
1.42 kilograms
Standard Deviation 3.03
|
|
ADDENDUM: Incremental Change From Baseline in Body Weight
Week 12 change (n=150,158,173,187)
|
0.43 kilograms
Standard Deviation 2.61
|
0.54 kilograms
Standard Deviation 2.36
|
0.27 kilograms
Standard Deviation 3.31
|
0.83 kilograms
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=170 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=173 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=198 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=200 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Body Weight
Week 12 (n=151,158,174,187)
|
91.59 kilograms
Standard Deviation 22.88
|
94.60 kilograms
Standard Deviation 25.08
|
89.62 kilograms
Standard Deviation 22.04
|
91.19 kilograms
Standard Deviation 23.68
|
|
ADDENDUM: Body Weight
Week 24 (n=145,151,164,176)
|
91.92 kilograms
Standard Deviation 23.32
|
94.18 kilograms
Standard Deviation 24.99
|
89.80 kilograms
Standard Deviation 21.95
|
91.22 kilograms
Standard Deviation 23.30
|
|
ADDENDUM: Body Weight
Baseline (n=170,173,198,200)
|
91.85 kilograms
Standard Deviation 23.41
|
93.63 kilograms
Standard Deviation 24.21
|
89.25 kilograms
Standard Deviation 21.62
|
90.09 kilograms
Standard Deviation 23.45
|
|
ADDENDUM: Body Weight
Week 6 (n=162,163,184,193)
|
91.53 kilograms
Standard Deviation 23.33
|
93.71 kilograms
Standard Deviation 24.82
|
89.66 kilograms
Standard Deviation 21.97
|
89.85 kilograms
Standard Deviation 22.50
|
|
ADDENDUM: Body Weight
Endpoint (n=164,170,192,198)
|
92.40 kilograms
Standard Deviation 23.67
|
94.09 kilograms
Standard Deviation 24.65
|
90.09 kilograms
Standard Deviation 21.95
|
91.45 kilograms
Standard Deviation 23.64
|
SECONDARY outcome
Timeframe: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=171 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=174 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=199 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=200 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Insulin Dose
Baseline (n=171,174,199,200)
|
0.55 units/kg/day
Standard Deviation 0.26
|
0.55 units/kg/day
Standard Deviation 0.25
|
0.46 units/kg/day
Standard Deviation 0.27
|
0.46 units/kg/day
Standard Deviation 0.24
|
|
ADDENDUM: Insulin Dose
Week 1 (n=152,158,183,183)
|
0.58 units/kg/day
Standard Deviation 0.26
|
0.57 units/kg/day
Standard Deviation 0.25
|
0.49 units/kg/day
Standard Deviation 0.27
|
0.49 units/kg/day
Standard Deviation 0.25
|
|
ADDENDUM: Insulin Dose
Week 2 (n=147,159,180,187)
|
0.63 units/kg/day
Standard Deviation 0.29
|
0.59 units/kg/day
Standard Deviation 0.26
|
0.54 units/kg/day
Standard Deviation 0.29
|
0.53 units/kg/day
Standard Deviation 0.24
|
|
ADDENDUM: Insulin Dose
Week 3 (n=149,158,179,184)
|
0.65 units/kg/day
Standard Deviation 0.28
|
0.64 units/kg/day
Standard Deviation 0.26
|
0.57 units/kg/day
Standard Deviation 0.28
|
0.58 units/kg/day
Standard Deviation 0.24
|
|
ADDENDUM: Insulin Dose
Week 4 (n=145,157,178,178)
|
0.69 units/kg/day
Standard Deviation 0.29
|
0.67 units/kg/day
Standard Deviation 0.27
|
0.63 units/kg/day
Standard Deviation 0.34
|
0.61 units/kg/day
Standard Deviation 0.25
|
|
ADDENDUM: Insulin Dose
Week 5 (n=148,153,172,173)
|
0.73 units/kg/day
Standard Deviation 0.29
|
0.70 units/kg/day
Standard Deviation 0.28
|
0.65 units/kg/day
Standard Deviation 0.34
|
0.65 units/kg/day
Standard Deviation 0.26
|
|
ADDENDUM: Insulin Dose
Week 8 (n=139,154,164,174)
|
0.76 units/kg/day
Standard Deviation 0.29
|
0.75 units/kg/day
Standard Deviation 0.32
|
0.71 units/kg/day
Standard Deviation 0.38
|
0.69 units/kg/day
Standard Deviation 0.29
|
|
ADDENDUM: Insulin Dose
Week 10 (n=141,152,158,174)
|
0.78 units/kg/day
Standard Deviation 0.31
|
0.77 units/kg/day
Standard Deviation 0.32
|
0.76 units/kg/day
Standard Deviation 0.43
|
0.73 units/kg/day
Standard Deviation 0.31
|
|
ADDENDUM: Insulin Dose
Week 12 (n=152,161,177,190)
|
0.80 units/kg/day
Standard Deviation 0.33
|
0.79 units/kg/day
Standard Deviation 0.33
|
0.77 units/kg/day
Standard Deviation 0.42
|
0.74 units/kg/day
Standard Deviation 0.32
|
|
ADDENDUM: Insulin Dose
Week 24 (n=147,151,166,179)
|
0.82 units/kg/day
Standard Deviation 0.35
|
0.80 units/kg/day
Standard Deviation 0.35
|
0.79 units/kg/day
Standard Deviation 0.45
|
0.76 units/kg/day
Standard Deviation 0.32
|
|
ADDENDUM: Insulin Dose
Week 6 (n=162,168,190,196)
|
0.73 units/kg/day
Standard Deviation 0.29
|
0.72 units/kg/day
Standard Deviation 0.29
|
0.68 units/kg/day
Standard Deviation 0.37
|
0.66 units/kg/day
Standard Deviation 0.28
|
|
ADDENDUM: Insulin Dose
Endpoint (n=165,170,199,200)
|
0.81 units/kg/day
Standard Deviation 0.35
|
0.79 units/kg/day
Standard Deviation 0.35
|
0.77 units/kg/day
Standard Deviation 0.43
|
0.76 units/kg/day
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=164 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=171 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=192 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=198 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia episodes endpoint
|
40.9 percentage of participants
|
41.5 percentage of participants
|
34.9 percentage of participants
|
40.9 percentage of participants
|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Overall hypoglycemia episodes
|
53.7 percentage of participants
|
56.1 percentage of participants
|
47.9 percentage of participants
|
56.1 percentage of participants
|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe episodes endpoint
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Severe episodes overall
|
0.0 percentage of participants
|
1.2 percentage of participants
|
0.0 percentage of participants
|
1.0 percentage of participants
|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal episodes endpoint
|
25.0 percentage of participants
|
20.5 percentage of participants
|
19.3 percentage of participants
|
23.7 percentage of participants
|
|
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Nocturnal episodes overall
|
31.1 percentage of participants
|
31.0 percentage of participants
|
27.1 percentage of participants
|
36.9 percentage of participants
|
SECONDARY outcome
Timeframe: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phasePopulation: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Outcome measures
| Measure |
Insulin Glargine
n=171 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=198 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=164 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=192 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Endpoint
|
11.10 episodes/participant/year
Standard Deviation 20.36
|
10.11 episodes/participant/year
Standard Deviation 21.84
|
12.11 episodes/participant/year
Standard Deviation 28.20
|
11.18 episodes/participant/year
Standard Deviation 44.80
|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Overall
|
2.47 episodes/participant/year
Standard Deviation 6.29
|
3.14 episodes/participant/year
Standard Deviation 6.58
|
2.09 episodes/participant/year
Standard Deviation 5.25
|
2.15 episodes/participant/year
Standard Deviation 5.56
|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Endpoint
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Severe episodes Overall
|
0.02 episodes/participant/year
Standard Deviation 0.23
|
0.02 episodes/participant/year
Standard Deviation 0.21
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
0.00 episodes/participant/year
Standard Deviation 0.00
|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia episodes Overall
|
11.54 episodes/participant/year
Standard Deviation 18.70
|
10.73 episodes/participant/year
Standard Deviation 18.06
|
11.39 episodes/participant/year
Standard Deviation 22.75
|
9.04 episodes/participant/year
Standard Deviation 21.45
|
|
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Nocturnal episodes Endpoint
|
2.46 episodes/participant/year
Standard Deviation 8.14
|
2.51 episodes/participant/year
Standard Deviation 7.03
|
2.37 episodes/participant/year
Standard Deviation 6.10
|
3.01 episodes/participant/year
Standard Deviation 13.62
|
SECONDARY outcome
Timeframe: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=166 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=172 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=197 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=199 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Baseline (n=166,172,197,199)
|
7.84 ug/mL
Standard Deviation 5.27
|
7.77 ug/mL
Standard Deviation 5.01
|
7.31 ug/mL
Standard Deviation 4.99
|
7.37 ug/mL
Standard Deviation 5.07
|
|
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Endpoint (n=142,150,165,171)
|
8.18 ug/mL
Standard Deviation 6.27
|
7.73 ug/mL
Standard Deviation 5.74
|
8.43 ug/mL
Standard Deviation 6.17
|
8.14 ug/mL
Standard Deviation 5.21
|
|
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Change (n=142,150,165,171)
|
0.26 ug/mL
Standard Deviation 4.40
|
-0.18 ug/mL
Standard Deviation 4.91
|
0.90 ug/mL
Standard Deviation 4.31
|
0.53 ug/mL
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Outcome measures
| Measure |
Insulin Glargine
n=174 Participants
Insulin glargine for 24 weeks.
|
Lispro Low Mix
n=200 Participants
Lispro Low Mix (LM) for 24 weeks.
|
Basal Bolus Prior Lispro Low Mix Addendum
n=171 Participants
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
Basal Bolus Prior Glargine Addendum
n=199 Participants
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
|
|---|---|---|---|---|
|
ADDENDUM: HbA1c at Specified Visits and Endpoint
Baseline (n=174,200,171,199)
|
8.01 percent glycosylated hemoglobin
Standard Deviation 0.93
|
8.03 percent glycosylated hemoglobin
Standard Deviation 0.95
|
8.00 percent glycosylated hemoglobin
Standard Deviation 0.92
|
7.98 percent glycosylated hemoglobin
Standard Deviation 0.95
|
|
ADDENDUM: HbA1c at Specified Visits and Endpoint
Week 12 (n=150,175,151,161)
|
8.11 percent glycosylated hemoglobin
Standard Deviation 1.06
|
8.07 percent glycosylated hemoglobin
Standard Deviation 1.20
|
8.13 percent glycosylated hemoglobin
Standard Deviation 1.26
|
8.19 percent glycosylated hemoglobin
Standard Deviation 1.38
|
|
ADDENDUM: HbA1c at Specified Visits and Endpoint
Week 24 (n=145,171,144,159)
|
8.19 percent glycosylated hemoglobin
Standard Deviation 1.27
|
8.05 percent glycosylated hemoglobin
Standard Deviation 1.18
|
8.19 percent glycosylated hemoglobin
Standard Deviation 1.47
|
8.14 percent glycosylated hemoglobin
Standard Deviation 1.55
|
|
ADDENDUM: HbA1c at Specified Visits and Endpoint
Endpoint (n=160, 187,159,176)
|
8.19 percent glycosylated hemoglobin
Standard Deviation 1.26
|
8.03 percent glycosylated hemoglobin
Standard Deviation 1.15
|
8.16 percent glycosylated hemoglobin
Standard Deviation 1.43
|
8.14 percent glycosylated hemoglobin
Standard Deviation 1.53
|
Adverse Events
Insulin Glargine Initiation
Serious events: 45 serious events
Other events: 785 other events
Deaths: 0 deaths
Lispro LM Initiation
Serious events: 65 serious events
Other events: 826 other events
Deaths: 0 deaths
Lispro Mid Mix Prior Lispro LM Addendum
Serious events: 5 serious events
Other events: 96 other events
Deaths: 0 deaths
Lispro LM Prior Glargine Addendum
Serious events: 10 serious events
Other events: 111 other events
Deaths: 0 deaths
Basal Bolus Prior Lispro LM Addendum
Serious events: 9 serious events
Other events: 88 other events
Deaths: 0 deaths
Basal Bolus Prior Glargine Addendum
Serious events: 11 serious events
Other events: 92 other events
Deaths: 0 deaths
Insulin Glargine Maintenance
Serious events: 48 serious events
Other events: 394 other events
Deaths: 0 deaths
Lispro LM Maintenance
Serious events: 48 serious events
Other events: 463 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glargine Initiation
n=1024 participants at risk；n=1046 participants at risk
|
Lispro LM Initiation
n=1026 participants at risk；n=1045 participants at risk
|
Lispro Mid Mix Prior Lispro LM Addendum
n=171 participants at risk；n=174 participants at risk
|
Lispro LM Prior Glargine Addendum
n=198 participants at risk；n=200 participants at risk
|
Basal Bolus Prior Lispro LM Addendum
n=164 participants at risk；n=171 participants at risk
|
Basal Bolus Prior Glargine Addendum
n=192 participants at risk；n=199 participants at risk
|
Insulin Glargine Maintenance
n=419 participants at risk
|
Lispro LM Maintenance
n=473 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign female reproductive tract neoplasm
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
1.0%
2/199 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.29%
3/1045 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.72%
3/419 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.63%
3/473 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.38%
4/1045 • Number of events 4
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.57%
1/174 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Migraine
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Psychiatric disorders
Major depression
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.57%
1/174 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.38%
4/1045 • Number of events 4
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.57%
1/174 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.63%
3/473 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
4/1046 • Number of events 4
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.63%
3/473 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.29%
3/1045 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Eye disorders
Cataract
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
1.0%
2/200 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Chest discomfort
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Chest pain
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Fatigue
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Gait disturbance
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
General disorders
Non-cardiac chest pain
|
0.19%
2/1046 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/200 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Bronchitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.57%
1/174 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
1.2%
2/171 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.72%
3/419 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Diabetic foot infection
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Diverticulitis
|
0.19%
2/1046 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Gangrene
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Localised infection
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Nail bed infection
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Pneumonia
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Postoperative infection
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
2/1046 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.42%
2/473 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
2/1046 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Investigations
Weight increased
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.48%
2/419 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.57%
1/174 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.29%
3/1045 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.58%
1/171 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.63%
3/473 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.19%
2/1045 • Number of events 3
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.50%
1/199 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.21%
1/473 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 2
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Aortic dissection
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.10%
1/1045 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Shock
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Thrombophlebitis
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.10%
1/1046 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/419
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/1046
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/1045
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/174
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/200
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/171
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/199
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.24%
1/419 • Number of events 1
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
0.00%
0/473
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
Other adverse events
| Measure |
Insulin Glargine Initiation
n=1024 participants at risk；n=1046 participants at risk
|
Lispro LM Initiation
n=1026 participants at risk；n=1045 participants at risk
|
Lispro Mid Mix Prior Lispro LM Addendum
n=171 participants at risk；n=174 participants at risk
|
Lispro LM Prior Glargine Addendum
n=198 participants at risk；n=200 participants at risk
|
Basal Bolus Prior Lispro LM Addendum
n=164 participants at risk；n=171 participants at risk
|
Basal Bolus Prior Glargine Addendum
n=192 participants at risk；n=199 participants at risk
|
Insulin Glargine Maintenance
n=419 participants at risk
|
Lispro LM Maintenance
n=473 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
76.7%
785/1024 • Number of events 9994
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
80.5%
826/1026 • Number of events 13164
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
56.1%
96/171 • Number of events 905
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
56.1%
111/198 • Number of events 927
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
53.7%
88/164 • Number of events 869
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
47.9%
92/192 • Number of events 785
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
94.0%
394/419 • Number of events 16861
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
97.9%
463/473 • Number of events 22562
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60