Trial Outcomes & Findings for A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients (NCT NCT00666718)
NCT ID: NCT00666718
Last Updated: 2011-05-13
Results Overview
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2011-05-13
Participant Flow
Participant milestones
| Measure |
Glargine
Glargine plus Insulin Lispro (2-3 injections) plus metformin
|
ILPS
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
|---|---|---|
|
Overall Study
STARTED
|
187
|
187
|
|
Overall Study
COMPLETED
|
175
|
169
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
Reasons for withdrawal
| Measure |
Glargine
Glargine plus Insulin Lispro (2-3 injections) plus metformin
|
ILPS
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
Glargine
n=187 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin
|
ILPS
n=187 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.3 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
186 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
42 participants
n=5 Participants
|
35 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
2 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
19 participants
n=5 Participants
|
26 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
32 participants
n=5 Participants
|
43 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
15 participants
n=5 Participants
|
25 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
22 participants
n=5 Participants
|
12 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
1 Insulin Injection/Inhalation per day
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
2 Insulin Injections/Inhalations per day
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
3 Insulin Injections/Inhalations per day
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
4 Insulin Injections/Inhalations per day
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
>=5 Insulin Injections/Inhalations per day
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of Insulin Injections/Inhalations Per Day
Missing Data
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Weight
|
93.53 kilograms (kg)
STANDARD_DEVIATION 17.168 • n=5 Participants
|
90.60 kilograms (kg)
STANDARD_DEVIATION 17.075 • n=7 Participants
|
92.06 kilograms (kg)
STANDARD_DEVIATION 17.161 • n=5 Participants
|
|
Body Mass Index (BMI)
|
33.27 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.040 • n=5 Participants
|
33.00 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.004 • n=7 Participants
|
33.13 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.017 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.83 Percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.896 • n=5 Participants
|
8.82 Percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.895 • n=7 Participants
|
8.82 Percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.894 • n=5 Participants
|
|
Duration of Diabetes
|
12.7 Years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
11.8 Years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
12.3 Years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
|
Previous Insulin Treatment
|
36.9 Units (IU)
STANDARD_DEVIATION 25.65 • n=5 Participants
|
37.6 Units (IU)
STANDARD_DEVIATION 25.75 • n=7 Participants
|
37.3 Units (IU)
STANDARD_DEVIATION 25.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=148 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
|
-1.28 Percent of Glycosylated Hemoglobin
Standard Error 0.08
|
-1.18 Percent of Glycosylated Hemoglobin
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
Outcome measures
| Measure |
Glargine
n=180 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=179 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 12 and Week 24
Week 12 Change (n=172, n=168)
|
-0.99 Percent of Glycosylated Hemoglobin
Interval -1.14 to -0.84
|
-0.90 Percent of Glycosylated Hemoglobin
Interval -1.1 to -0.69
|
|
Change From Baseline in HbA1c at Week 12 and Week 24
Week 24 Change (n=170, n=166)
|
-1.29 Percent of Glycosylated Hemoglobin
Interval -1.45 to -1.13
|
-1.07 Percent of Glycosylated Hemoglobin
Interval -1.28 to -0.86
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Outcome measures
| Measure |
Glargine
n=180 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=179 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
HbA1c < 7.0%
|
50 Percent of Participants
|
36 Percent of Participants
|
|
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
HbA1c <= 6.5%
|
24 Percent of Participants
|
14 Percent of Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.
Outcome measures
| Measure |
Glargine
n=180 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=179 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Morning Pre-Meal
|
8.26 millimoles per liter (mmol/L)
Standard Error 0.22
|
8.63 millimoles per liter (mmol/L)
Standard Error 0.34
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Morning Postprandial
|
8.93 millimoles per liter (mmol/L)
Standard Error 0.25
|
9.19 millimoles per liter (mmol/L)
Standard Error 0.40
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Midday Pre-Meal
|
8.19 millimoles per liter (mmol/L)
Standard Error 0.23
|
7.90 millimoles per liter (mmol/L)
Standard Error 0.37
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Midday Postprandial
|
9.11 millimoles per liter (mmol/L)
Standard Error 0.25
|
9.58 millimoles per liter (mmol/L)
Standard Error 0.40
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Evening Pre-Meal
|
8.80 millimoles per liter (mmol/L)
Standard Error 0.24
|
8.75 millimoles per liter (mmol/L)
Standard Error 0.38
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Evening Postprandial
|
9.27 millimoles per liter (mmol/L)
Standard Error 0.24
|
9.73 millimoles per liter (mmol/L)
Standard Error 0.37
|
|
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
0300 Hours
|
8.16 millimoles per liter (mmol/L)
Standard Error 0.22
|
8.30 millimoles per liter (mmol/L)
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
Outcome measures
| Measure |
Glargine
n=180 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=179 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Glycemic Variability at Endpoint
Fasting
|
0.86 mmol/L
Standard Error 0.10
|
0.95 mmol/L
Standard Error 0.10
|
|
Glycemic Variability at Endpoint
Post-breakfast
|
1.56 mmol/L
Standard Error 0.17
|
1.64 mmol/L
Standard Error 0.18
|
|
Glycemic Variability at Endpoint
Post-lunch
|
1.61 mmol/L
Standard Error 0.15
|
1.51 mmol/L
Standard Error 0.16
|
|
Glycemic Variability at Endpoint
Post-dinner
|
1.43 mmol/L
Standard Error 0.17
|
1.40 mmol/L
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Safety population - all participants who received at least one dose of study drug.
Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Outcome measures
| Measure |
Glargine
n=187 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=187 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Rate Of All Self-reported Hypoglycemic Episodes
All reported episodes rate
|
1.38 episode/30 days/participant
Standard Error 0.21
|
0.84 episode/30 days/participant
Standard Error 0.26
|
|
Rate Of All Self-reported Hypoglycemic Episodes
Nocturnal reported episodes rate
|
0.19 episode/30 days/participant
Standard Error 0.05
|
0.15 episode/30 days/participant
Standard Error 0.06
|
|
Rate Of All Self-reported Hypoglycemic Episodes
Non-Nocturnal reported episodes rate
|
1.16 episode/30 days/participant
Standard Error 0.20
|
0.71 episode/30 days/participant
Standard Error 0.24
|
|
Rate Of All Self-reported Hypoglycemic Episodes
Severe reported episodes rate
|
0 episode/30 days/participant
Standard Error 0.013
|
0 episode/30 days/participant
Standard Error 0.029
|
|
Rate Of All Self-reported Hypoglycemic Episodes
Documented <=3.9 millimoles per liter(mmol/L) rate
|
0.89 episode/30 days/participant
Standard Error 0.15
|
0.49 episode/30 days/participant
Standard Error 0.18
|
|
Rate Of All Self-reported Hypoglycemic Episodes
Documented <=3.0 mmol/L rate
|
0.13 episode/30 days/participant
Standard Error 0.04
|
0.12 episode/30 days/participant
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Safety population - all participants who received at least one dose of study drug.
Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Outcome measures
| Measure |
Glargine
n=187 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=187 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Percentage of Participants With Self-Reported Hypoglycemic Episodes
>=1 hypoglycemic episode
|
63.6 percentage of participants
|
56.1 percentage of participants
|
|
Percentage of Participants With Self-Reported Hypoglycemic Episodes
>=1 nocturnal hypoglycemic episode
|
19.3 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants With Self-Reported Hypoglycemic Episodes
>=1 non-nocturnal hypoglycemic episode
|
61.0 percentage of participants
|
54.0 percentage of participants
|
|
Percentage of Participants With Self-Reported Hypoglycemic Episodes
>=1 severe hypoglycemic episode
|
0.5 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Safety population - all participants who received at least one dose of study drug.
A listing of adverse events is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Glargine
n=187 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=187 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
AEs
|
81 participants
|
65 participants
|
|
Number of Participants With Adverse Events (AE)
Serious adverse events (SAE)
|
9 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Outcome measures
| Measure |
Glargine
n=187 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=187 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 24
|
1.19 Kilograms (kg)
Standard Error 0.27
|
1.03 Kilograms (kg)
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Outcome measures
| Measure |
Glargine
n=180 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=179 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Total Daily Insulin Dose at Endpoint
|
78.05 Units
Standard Error 3.15
|
80.23 Units
Standard Error 4.31
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Outcome measures
| Measure |
Glargine
n=141 Participants
Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
|
ILPS
n=113 Participants
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
|
|---|---|---|
|
Number of Injections of Insulin at Week 24
2 to <3 per day
|
8 Participants
|
10 Participants
|
|
Number of Injections of Insulin at Week 24
3 to <4 per day
|
129 Participants
|
102 Participants
|
|
Number of Injections of Insulin at Week 24
≥4 per day
|
4 Participants
|
1 Participants
|
Adverse Events
Glargine/Lispro
Serious events: 9 serious events
Other events: 81 other events
Deaths: 0 deaths
Lispro/Metformin
Serious events: 14 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glargine/Lispro
n=187 participants at risk
Glargine plus Insulin Lispro (2-3 injections) plus metformin
|
Lispro/Metformin
n=187 participants at risk
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.53%
1/187 • Number of events 1
|
0.53%
1/187 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Coronary artery disease
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Coronary artery perforation
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Myocardial infarction
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Cardiac disorders
Myocardial ischaemia
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
General disorders
Impaired healing
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
General disorders
Oedema mucosal
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.53%
1/187 • Number of events 1
|
0.00%
0/187
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Surgical and medical procedures
Physiotherapy
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/187
|
0.53%
1/187 • Number of events 1
|
Other adverse events
| Measure |
Glargine/Lispro
n=187 participants at risk
Glargine plus Insulin Lispro (2-3 injections) plus metformin
|
Lispro/Metformin
n=187 participants at risk
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
3/187 • Number of events 3
|
0.00%
0/187
|
|
Eye disorders
Diabetic retinopathy
|
0.53%
1/187 • Number of events 1
|
1.6%
3/187 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
3/187 • Number of events 4
|
1.1%
2/187 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
8/187 • Number of events 8
|
1.6%
3/187 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
2.7%
5/187 • Number of events 6
|
0.53%
1/187 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.1%
2/187 • Number of events 2
|
2.1%
4/187 • Number of events 6
|
|
General disorders
Chest discomfort
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
General disorders
Fatigue
|
0.53%
1/187 • Number of events 1
|
1.1%
2/187 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
1.6%
3/187 • Number of events 3
|
0.00%
0/187
|
|
Infections and infestations
Cystitis
|
2.7%
5/187 • Number of events 5
|
0.53%
1/187 • Number of events 1
|
|
Infections and infestations
Influenza
|
2.7%
5/187 • Number of events 5
|
2.1%
4/187 • Number of events 4
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
12/187 • Number of events 17
|
5.3%
10/187 • Number of events 12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/187
|
1.1%
2/187 • Number of events 2
|
|
Infections and infestations
Pulpitis dental
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Rhinitis
|
1.6%
3/187 • Number of events 4
|
1.6%
3/187 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Tonsillitis
|
2.1%
4/187 • Number of events 4
|
0.53%
1/187 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.53%
1/187 • Number of events 1
|
1.1%
2/187 • Number of events 2
|
|
Infections and infestations
Viral infection
|
2.7%
5/187 • Number of events 7
|
3.7%
7/187 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
5/187 • Number of events 7
|
1.6%
3/187 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
6/187 • Number of events 7
|
1.6%
3/187 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/187
|
1.6%
3/187 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
3/187 • Number of events 3
|
0.00%
0/187
|
|
Nervous system disorders
Diabetic neuropathy
|
1.1%
2/187 • Number of events 2
|
0.53%
1/187 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.9%
11/187 • Number of events 20
|
4.8%
9/187 • Number of events 39
|
|
Nervous system disorders
Sciatica
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Nervous system disorders
Tremor
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Psychiatric disorders
Anxiety
|
1.6%
3/187 • Number of events 4
|
0.00%
0/187
|
|
Psychiatric disorders
Depression
|
0.00%
0/187
|
1.1%
2/187 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
1.1%
2/187 • Number of events 7
|
0.00%
0/187
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/187
|
1.1%
2/187 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
7/187 • Number of events 9
|
2.1%
4/187 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
4/187 • Number of events 4
|
1.6%
3/187 • Number of events 3
|
|
Surgical and medical procedures
Cataract operation
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Vascular disorders
Hypertension
|
1.1%
2/187 • Number of events 2
|
2.1%
4/187 • Number of events 4
|
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