Trial Outcomes & Findings for Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (NCT NCT00377858)
NCT ID: NCT00377858
Last Updated: 2009-12-09
Results Overview
Level of hemoglobin A1c at endpoint.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
484 participants
Primary outcome timeframe
36 weeks
Results posted on
2009-12-09
Participant Flow
636 patients were screened; 128 were screen failures; 24 discontinued prior to randomization; 484 patients were randomized. Baseline Characteristics are provided for the Intent to Treat Population, which was defined as patients with baseline and at least one post-baseline value.
Participant milestones
| Measure |
Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
242
|
242
|
|
Overall Study
Had at Least One Post-Baseline Value
|
239
|
240
|
|
Overall Study
COMPLETED
|
211
|
215
|
|
Overall Study
NOT COMPLETED
|
31
|
27
|
Reasons for withdrawal
| Measure |
Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Physician Decision
|
5
|
5
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Entry Criteria Not Met
|
2
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
2
|
|
Overall Study
Death
|
0
|
3
|
Baseline Characteristics
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Baseline characteristics by cohort
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.40 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
59.45 years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
58.92 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
India
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
BMI <25 kg/m^2
|
34 participants
n=5 Participants
|
48 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
BMI ≥25 kg/m^2 and <30 kg/m^2
|
106 participants
n=5 Participants
|
103 participants
n=7 Participants
|
209 participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
BMI ≥30 kg/m^2
|
99 participants
n=5 Participants
|
89 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
Duration of Diabetes Group
<5 years
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Duration of Diabetes Group
≥5 years and ≤10 years
|
95 participants
n=5 Participants
|
100 participants
n=7 Participants
|
195 participants
n=5 Participants
|
|
Duration of Diabetes Group
>10 years
|
116 participants
n=5 Participants
|
113 participants
n=7 Participants
|
229 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c) Group
≤8.5% HbA1c
|
60 participants
n=5 Participants
|
67 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c) Group
>8.5% HbA1c
|
179 participants
n=5 Participants
|
173 participants
n=7 Participants
|
352 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
134 participants
n=5 Participants
|
136 participants
n=7 Participants
|
270 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
51 participants
n=5 Participants
|
46 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Race/Ethnicity
West Asian (Indian sub-continent)
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Body Height
|
163.27 centimeters (cm)
STANDARD_DEVIATION 9.27 • n=5 Participants
|
164.68 centimeters (cm)
STANDARD_DEVIATION 9.48 • n=7 Participants
|
163.98 centimeters (cm)
STANDARD_DEVIATION 9.39 • n=5 Participants
|
|
Body Mass Index (BMI)
|
29.51 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.76 • n=5 Participants
|
29.00 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.55 • n=7 Participants
|
29.25 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.66 • n=5 Participants
|
|
Body Weight
|
78.85 kilograms (kg)
STANDARD_DEVIATION 15.50 • n=5 Participants
|
78.87 kilograms (kg)
STANDARD_DEVIATION 15.10 • n=7 Participants
|
78.86 kilograms (kg)
STANDARD_DEVIATION 15.28 • n=5 Participants
|
|
Duration of Diabetes
|
10.86 years
STANDARD_DEVIATION 5.54 • n=5 Participants
|
11.79 years
STANDARD_DEVIATION 7.29 • n=7 Participants
|
11.33 years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
9.55 percent HbA1c
STANDARD_DEVIATION 1.18 • n=5 Participants
|
9.39 percent HbA1c
STANDARD_DEVIATION 1.17 • n=7 Participants
|
9.47 percent HbA1c
STANDARD_DEVIATION 1.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Number of participants in the per-protocol population. Last observation carried forward.
Level of hemoglobin A1c at endpoint.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=188 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=195 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) at 36 Week Endpoint
|
7.66 percent HbA1c
Standard Error 0.37
|
7.49 percent HbA1c
Standard Error 0.36
|
SECONDARY outcome
Timeframe: 12, 24, and 36 weeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.
Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=222 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=222 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) at Interval Visits
12 Week Interval (n=222, n=222)
|
8.02 percent HbA1c
Standard Error 0.32
|
7.85 percent HbA1c
Standard Error 0.31
|
|
Hemoglobin A1c (HbA1c) at Interval Visits
24 Week Interval (n=206, n=217)
|
7.53 percent HbA1c
Standard Error 0.33
|
7.36 percent HbA1c
Standard Error 0.32
|
|
Hemoglobin A1c (HbA1c) at Interval Visits
36 Week Interval (n=202, n=208)
|
7.53 percent HbA1c
Standard Error 0.37
|
7.44 percent HbA1c
Standard Error 0.37
|
SECONDARY outcome
Timeframe: 12-24-36 weeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=234 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=235 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c ≤7.0% (n=222, n=222)
|
21.2 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c >7.0% (n=222, n=222)
|
78.8 percentage of participants
|
74.8 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c <7.0% (n=222, n=222)
|
18.9 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c ≥7.0% (n=222, n=222)
|
81.1 percentage of participants
|
78.4 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c ≤6.5% (n=222, n=222)
|
8.1 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 12: HbA1c >6.5% (n=222, n=222)
|
91.9 percentage of participants
|
89.2 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c ≤7.0% (n=206, n=217)
|
39.8 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c >7.0% (n=206, n=217)
|
60.2 percentage of participants
|
53.0 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c <7.0% (n=206, n=217)
|
35.4 percentage of participants
|
38.7 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c ≥7.0% (n=206, n=217)
|
64.6 percentage of participants
|
61.3 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c ≤6.5% (n=206, n=217)
|
16.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 24: HbA1c >6.5% (n=206, n=217)
|
84.0 percentage of participants
|
78.3 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c ≤7.0% (n=202, n=208)
|
39.6 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c >7.0% (n=202, n=208)
|
60.4 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c <7.0% (n=202, n=208)
|
37.6 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c ≥7.0% (n=202, n=208)
|
62.4 percentage of participants
|
59.6 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c ≤6.5% (n=202, n=208)
|
15.3 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Week 36: HbA1c >6.5% (n=202, n=208)
|
84.7 percentage of participants
|
80.8 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c ≤7.0% (n=234, n=235)
|
36.8 percentage of participants
|
43.0 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c >7.0% (n=234, n=235)
|
63.2 percentage of participants
|
57.0 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c <7.0% (n=234, n=235)
|
35.0 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c ≥7.0% (n=234, n=235)
|
65.0 percentage of participants
|
60.9 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c ≤6.5% (n=234, n=235)
|
13.2 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Endpoint (LOCF): HbA1c >6.5% (n=234, n=235)
|
86.8 percentage of participants
|
80.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12-24-36 weeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
Actual daily mean blood glucose levels at specified time points.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Morning Pre-Meal (n=228, n=231)
|
10.22 millimoles per Liter (mmol/L)
Standard Error 0.91
|
9.64 millimoles per Liter (mmol/L)
Standard Error 0.90
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Morning Postprandial Meal (n=213, n=222)
|
12.49 millimoles per Liter (mmol/L)
Standard Error 1.18
|
12.39 millimoles per Liter (mmol/L)
Standard Error 1.16
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Midday Pre-Meal (n=227, n=230)
|
10.15 millimoles per Liter (mmol/L)
Standard Error 1.07
|
9.62 millimoles per Liter (mmol/L)
Standard Error 1.05
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Midday Postprandial Meal (n=215, n=223)
|
11.40 millimoles per Liter (mmol/L)
Standard Error 1.12
|
11.22 millimoles per Liter (mmol/L)
Standard Error 1.10
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Evening Pre-Meal (n=227, n=229)
|
10.38 millimoles per Liter (mmol/L)
Standard Error 1.09
|
10.31 millimoles per Liter (mmol/L)
Standard Error 1.07
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: Evening Postprandial Meal (n=226,n= 229)
|
11.87 millimoles per Liter (mmol/L)
Standard Error 1.05
|
11.76 millimoles per Liter (mmol/L)
Standard Error 1.03
|
|
7-point Self-monitored Blood Glucose Profiles
Baseline: 0300 Hours (n=205, n=202)
|
9.37 millimoles per Liter (mmol/L)
Standard Error 1.08
|
9.17 millimoles per Liter (mmol/L)
Standard Error 1.06
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Morning Pre-Meal (n=218, n=226)
|
7.26 millimoles per Liter (mmol/L)
Standard Error 0.64
|
6.68 millimoles per Liter (mmol/L)
Standard Error 0.63
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Morning Postprandial Meal (n=192, n=206)
|
11.56 millimoles per Liter (mmol/L)
Standard Error 0.94
|
11.28 millimoles per Liter (mmol/L)
Standard Error 0.92
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Midday Pre-Meal (n=215, n=220)
|
8.63 millimoles per Liter (mmol/L)
Standard Error 0.76
|
8.10 millimoles per Liter (mmol/L)
Standard Error 0.75
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Midday Postprandial Meal (n=196, n=209)
|
9.92 millimoles per Liter (mmol/L)
Standard Error 0.91
|
9.43 millimoles per Liter (mmol/L)
Standard Error 0.89
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Evening Pre-Meal (n=216, n=221)
|
8.75 millimoles per Liter (mmol/L)
Standard Error 0.80
|
7.98 millimoles per Liter (mmol/L)
Standard Error 0.79
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: Evening Postprandial Meal (n=213, n= 223)
|
8.23 millimoles per Liter (mmol/L)
Standard Error 0.90
|
9.40 millimoles per Liter (mmol/L)
Standard Error 0.89
|
|
7-point Self-monitored Blood Glucose Profiles
12 Week: 0300 Hours (n=185, n=187)
|
6.97 millimoles per Liter (mmol/L)
Standard Error 0.79
|
7.12 millimoles per Liter (mmol/L)
Standard Error 0.78
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Morning Pre-Meal (n=210, n=213)
|
6.72 millimoles per Liter (mmol/L)
Standard Error 0.64
|
6.07 millimoles per Liter (mmol/L)
Standard Error 0.63
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Morning Postprandial Meal (n=193, n=201)
|
9.87 millimoles per Liter (mmol/L)
Standard Error 0.91
|
9.45 millimoles per Liter (mmol/L)
Standard Error 0.89
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Midday Pre-Meal (n=209, n=213)
|
7.99 millimoles per Liter (mmol/L)
Standard Error 0.79
|
7.82 millimoles per Liter (mmol/L)
Standard Error 0.77
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Midday Postprandial Meal (n=196, n=203)
|
9.38 millimoles per Liter (mmol/L)
Standard Error 0.90
|
9.15 millimoles per Liter (mmol/L)
Standard Error 0.88
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Evening Pre-Meal (n=209, n=211)
|
7.50 millimoles per Liter (mmol/L)
Standard Error 0.81
|
6.94 millimoles per Liter (mmol/L)
Standard Error 0.79
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: Evening Postprandial Meal (n=207, n= 207)
|
8.21 millimoles per Liter (mmol/L)
Standard Error 0.82
|
8.69 millimoles per Liter (mmol/L)
Standard Error 0.81
|
|
7-point Self-monitored Blood Glucose Profiles
24 Week: 0300 Hours (n=181, n=184)
|
7.14 millimoles per Liter (mmol/L)
Standard Error 0.71
|
7.18 millimoles per Liter (mmol/L)
Standard Error 0.70
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Morning Pre-Meal (n=200, n=210)
|
6.96 millimoles per Liter (mmol/L)
Standard Error 0.67
|
6.48 millimoles per Liter (mmol/L)
Standard Error 0.65
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Morning Postprandial Meal (n=179, n=194)
|
10.09 millimoles per Liter (mmol/L)
Standard Error 0.92
|
10.29 millimoles per Liter (mmol/L)
Standard Error 0.90
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Midday Pre-Meal (n=199, n=210)
|
7.33 millimoles per Liter (mmol/L)
Standard Error 0.77
|
7.46 millimoles per Liter (mmol/L)
Standard Error 0.76
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Midday Postprandial Meal (n=182, n=195)
|
10.31 millimoles per Liter (mmol/L)
Standard Error 0.92
|
10.30 millimoles per Liter (mmol/L)
Standard Error 0.91
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Evening Pre-Meal (n=199, n=207)
|
8.13 millimoles per Liter (mmol/L)
Standard Error 0.81
|
7.97 millimoles per Liter (mmol/L)
Standard Error 0.79
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: Evening Postprandial Meal (n=195, n= 225)
|
9.46 millimoles per Liter (mmol/L)
Standard Error 0.85
|
9.85 millimoles per Liter (mmol/L)
Standard Error 0.83
|
|
7-point Self-monitored Blood Glucose Profiles
36 Week: 0300 Hours (n=167, n=177)
|
8.18 millimoles per Liter (mmol/L)
Standard Error 1.06
|
8.25 millimoles per Liter (mmol/L)
Standard Error 1.05
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Morning Pre-Meal (n=228, n=231)
|
6.98 millimoles per Liter (mmol/L)
Standard Error 0.68
|
6.53 millimoles per Liter (mmol/L)
Standard Error 0.67
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Morning Postprandial Meal (n=213, n=222)
|
9.98 millimoles per Liter (mmol/L)
Standard Error 0.94
|
10.29 millimoles per Liter (mmol/L)
Standard Error 0.92
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Midday Pre-Meal (n=227, n=230)
|
7.36 millimoles per Liter (mmol/L)
Standard Error 0.80
|
7.52 millimoles per Liter (mmol/L)
Standard Error 0.79
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Midday Postprandial Meal (n=215, n=223)
|
10.28 millimoles per Liter (mmol/L)
Standard Error 0.91
|
10.34 millimoles per Liter (mmol/L)
Standard Error 0.90
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Evening Pre-Meal (n=227, n=229)
|
8.15 millimoles per Liter (mmol/L)
Standard Error 0.81
|
7.98 millimoles per Liter (mmol/L)
Standard Error 0.80
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: Evening Postprandial Meal (n=226,n= 229)
|
9.27 millimoles per Liter (mmol/L)
Standard Error 0.85
|
9.84 millimoles per Liter (mmol/L)
Standard Error 0.83
|
|
7-point Self-monitored Blood Glucose Profiles
Endpoint: 0300 Hours (n=205, n=202)
|
7.78 millimoles per Liter (mmol/L)
Standard Error 0.75
|
7.89 millimoles per Liter (mmol/L)
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Baseline, 12-24-36 weeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Glycemic Variability
Baseline MODD (n=226, n=229)
|
2.09 millimoles per liter (mmol/L)
Standard Error 0.33
|
2.07 millimoles per liter (mmol/L)
Standard Error 0.32
|
|
Glycemic Variability
Baseline M-Value (n=228, n=231)
|
48.02 millimoles per liter (mmol/L)
Standard Error 14.73
|
46.75 millimoles per liter (mmol/L)
Standard Error 14.47
|
|
Glycemic Variability
12 Week MODD (n=214, n=221)
|
1.51 millimoles per liter (mmol/L)
Standard Error 0.31
|
1.54 millimoles per liter (mmol/L)
Standard Error 0.31
|
|
Glycemic Variability
12 Week M-Value (n=218, n=226)
|
30.07 millimoles per liter (mmol/L)
Standard Error 7.24
|
28.49 millimoles per liter (mmol/L)
Standard Error 7.12
|
|
Glycemic Variability
24 Week MODD (n=208, n=211)
|
1.57 millimoles per liter (mmol/L)
Standard Error 0.33
|
1.66 millimoles per liter (mmol/L)
Standard Error 0.32
|
|
Glycemic Variability
24 Week M-Value (n=210, n=213)
|
22.67 millimoles per liter (mmol/L)
Standard Error 7.05
|
20.14 millimoles per liter (mmol/L)
Standard Error 6.93
|
|
Glycemic Variability
36 Week MODD (n=198, n=206)
|
1.55 millimoles per liter (mmol/L)
Standard Error 0.32
|
1.60 millimoles per liter (mmol/L)
Standard Error 0.32
|
|
Glycemic Variability
36 Week M-Value (n=200, n=210)
|
26.46 millimoles per liter (mmol/L)
Standard Error 7.26
|
27.41 millimoles per liter (mmol/L)
Standard Error 7.12
|
|
Glycemic Variability
Endpoint MODD (n=226, n=229)
|
1.51 millimoles per liter (mmol/L)
Standard Error 0.32
|
1.61 millimoles per liter (mmol/L)
Standard Error 0.31
|
|
Glycemic Variability
Endpoint M-Value (n=228, n=231)
|
26.27 millimoles per liter (mmol/L)
Standard Error 7.41
|
27.99 millimoles per liter (mmol/L)
Standard Error 7.28
|
SECONDARY outcome
Timeframe: Baseline to 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Endpoint Hypoglycemic Episodes
|
87 participants
|
106 participants
|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Overall Hypoglycemic Episodes
|
178 participants
|
179 participants
|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Endpoint Nocturnal Hypoglycemic Episodes
|
30 participants
|
37 participants
|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Overall Nocturnal Hypoglycemic Episodes
|
112 participants
|
112 participants
|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Endpoint Non-Nocturnal Hypoglycemic Episodes
|
71 participants
|
98 participants
|
|
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Overall Non-Nocturnal Hypoglycemic Episodes
|
175 participants
|
179 participants
|
SECONDARY outcome
Timeframe: Baseline to 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Endpoint Hypoglycemic Rate
|
1.57 hypoglycemic event per 30 days
Standard Deviation 2.98
|
2.19 hypoglycemic event per 30 days
Standard Deviation 3.60
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Overall Hypoglycemic Rate
|
1.88 hypoglycemic event per 30 days
Standard Deviation 2.44
|
2.21 hypoglycemic event per 30 days
Standard Deviation 2.87
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Endpoint Nocturnal Hypoglycemic Rate
|
0.26 hypoglycemic event per 30 days
Standard Deviation 0.79
|
0.32 hypoglycemic event per 30 days
Standard Deviation 0.84
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Overall Nocturnal Hypoglycemic Rate
|
0.26 hypoglycemic event per 30 days
Standard Deviation 0.43
|
0.28 hypoglycemic event per 30 days
Standard Deviation 0.50
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Endpoint Non-Nocturnal Hypoglycemic Rate
|
1.31 hypoglycemic event per 30 days
Standard Deviation 2.80
|
1.87 hypoglycemic event per 30 days
Standard Deviation 3.29
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Overall Non-Nocturnal Hypoglycemic Rate
|
1.63 hypoglycemic event per 30 days
Standard Deviation 2.25
|
1.93 hypoglycemic event per 30 days
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Baseline to 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Number of Patients With at Least One Severe Hypoglycemia Episode
Endpoint Severe Hypoglycemic Episodes
|
1 participants
|
1 participants
|
|
Number of Patients With at Least One Severe Hypoglycemia Episode
Overall Severe Hypoglycemic Episodes
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \[U/kg/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Daily Basal (n=239, n=240)
|
0.27 U/kg/day
Standard Error 0.07
|
0.35 U/kg/day
Standard Error 0.07
|
|
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Daily Prandial (n=239, n=130)
|
0.36 U/kg/day
Standard Error 0.08
|
0.29 U/kg/day
Standard Error 0.08
|
|
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Daily Total (n=239, n=240)
|
0.57 U/kg/day
Standard Error 0.11
|
0.51 U/kg/day
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
Total daily insulin dose (Units of insulin per day \[U/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Endpoint Insulin Dose; Total, Basal, and Prandial
Daily Basal (n=239, n=240)
|
19.90 U/day
Standard Error 5.46
|
26.86 U/day
Standard Error 5.37
|
|
Endpoint Insulin Dose; Total, Basal, and Prandial
Daily Prandial (n=239, n=130)
|
27.73 U/day
Standard Error 6.23
|
21.68 U/day
Standard Error 6.19
|
|
Endpoint Insulin Dose; Total, Basal, and Prandial
Daily Total (n=239, n=240)
|
43.44 U/day
Standard Error 8.65
|
38.25 U/day
Standard Error 8.51
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 30, 36Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Number of Insulin Injections Per Day
Week 12
|
1.33 insulin injections
Standard Error 0.19
|
1.00 insulin injections
Standard Error 0.18
|
|
Number of Insulin Injections Per Day
Week 24
|
1.97 insulin injections
Standard Error 0.28
|
1.76 insulin injections
Standard Error 0.27
|
|
Number of Insulin Injections Per Day
Week 30
|
2.05 insulin injections
Standard Error 0.30
|
1.81 insulin injections
Standard Error 0.30
|
|
Number of Insulin Injections Per Day
Week 36
|
2.03 insulin injections
Standard Error 0.30
|
1.80 insulin injections
Standard Error 0.29
|
|
Number of Insulin Injections Per Day
Endpoint
|
1.98 insulin injections
Standard Error 0.30
|
1.79 insulin injections
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, 36 WeeksPopulation: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
Outcome measures
| Measure |
Insulin Lispro Mid Mixture
n=239 Participants
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 Participants
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Baseline
|
76.71 kilograms
Standard Error 5.09
|
77.00 kilograms
Standard Error 5.01
|
|
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Change from Baseline
|
3.09 kilograms
Standard Error 1.44
|
3.19 kilograms
Standard Error 1.42
|
Adverse Events
Insulin Lispro Mid Mixture
Serious events: 11 serious events
Other events: 91 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 11 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro Mid Mixture
n=239 participants at risk
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 participants at risk
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Cardiac disorders
Myocardial ischaemia
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Glaucoma
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Nervous system disorders
Convulsion
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Nervous system disorders
Headache
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.42%
1/239 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Vascular disorders
Angiopathy
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
|
Vascular disorders
Arterial disorder
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Vascular disorders
Extremity necrosis
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Vascular disorders
Phlebitis
|
0.42%
1/239 • Number of events 1
|
0.00%
0/240
|
|
Vascular disorders
Vasculitis
|
0.00%
0/239
|
0.42%
1/240 • Number of events 1
|
Other adverse events
| Measure |
Insulin Lispro Mid Mixture
n=239 participants at risk
Insulin lispro mid mixture (MM) up to three times a day (TID)
|
Insulin Glargine
n=240 participants at risk
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/239
|
1.2%
3/240 • Number of events 4
|
|
Eye disorders
Diabetic retinopathy
|
0.42%
1/239 • Number of events 1
|
1.7%
4/240 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
3/239 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.3%
3/239 • Number of events 4
|
0.00%
0/240
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
7/239 • Number of events 9
|
3.3%
8/240 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/239 • Number of events 4
|
1.2%
3/240 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
6/239 • Number of events 6
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Fatigue
|
1.7%
4/239 • Number of events 5
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Oedema peripheral
|
1.3%
3/239 • Number of events 3
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Pain
|
1.7%
4/239 • Number of events 7
|
0.00%
0/240
|
|
General disorders
Pyrexia
|
1.3%
3/239 • Number of events 5
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.5%
6/239 • Number of events 6
|
5.0%
12/240 • Number of events 12
|
|
Infections and infestations
Gastroenteritis
|
1.3%
3/239 • Number of events 4
|
1.2%
3/240 • Number of events 3
|
|
Infections and infestations
Influenza
|
1.3%
3/239 • Number of events 5
|
1.2%
3/240 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
8.4%
20/239 • Number of events 31
|
8.8%
21/240 • Number of events 22
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
4/239 • Number of events 7
|
2.5%
6/240 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
2.1%
5/239 • Number of events 5
|
1.7%
4/240 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.3%
3/239 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
3/239 • Number of events 3
|
1.7%
4/240 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.84%
2/239 • Number of events 2
|
2.5%
6/240 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
5/239 • Number of events 5
|
1.2%
3/240 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
3/239 • Number of events 3
|
0.83%
2/240 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
3/239 • Number of events 3
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
5/239 • Number of events 5
|
0.42%
1/240 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.3%
3/239 • Number of events 4
|
0.83%
2/240 • Number of events 3
|
|
Nervous system disorders
Headache
|
1.7%
4/239 • Number of events 6
|
0.42%
1/240 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.7%
4/239 • Number of events 4
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
4/239 • Number of events 4
|
1.2%
3/240 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
3/239 • Number of events 5
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
3/239 • Number of events 4
|
2.9%
7/240 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
3/239 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
3/239 • Number of events 3
|
0.00%
0/240
|
|
Vascular disorders
Hypertension
|
3.8%
9/239 • Number of events 9
|
1.7%
4/240 • 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