Trial Outcomes & Findings for Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) (NCT NCT00510952)
NCT ID: NCT00510952
Last Updated: 2010-10-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
471 participants
Primary outcome timeframe
Baseline, 24 Weeks
Results posted on
2010-10-21
Participant Flow
Participant milestones
| Measure |
Lispro
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
235
|
236
|
|
Overall Study
Full Analysis Set (Intent to Treat)
|
229
|
229
|
|
Overall Study
COMPLETED
|
209
|
220
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
Reasons for withdrawal
| Measure |
Lispro
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
7
|
4
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Did Not Receive Study Drug
|
2
|
0
|
Baseline Characteristics
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Baseline characteristics by cohort
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.05 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
57.29 years
STANDARD_DEVIATION 8.99 • n=7 Participants
|
57.67 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
India
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
147 participants
n=5 Participants
|
142 participants
n=7 Participants
|
289 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Race/Ethnicity
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
West Asian (Indian sub-continent)
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Sulfonylurea Group
Yes
|
191 participants
n=5 Participants
|
190 participants
n=7 Participants
|
381 participants
n=5 Participants
|
|
Sulfonylurea Group
No
|
38 participants
n=5 Participants
|
39 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.69 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.01 • n=5 Participants
|
31.62 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.48 • n=7 Participants
|
31.16 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.27 • n=5 Participants
|
|
Body Weight
|
84.23 kilograms (kg)
STANDARD_DEVIATION 16.83 • n=5 Participants
|
86.05 kilograms (kg)
STANDARD_DEVIATION 18.62 • n=7 Participants
|
85.14 kilograms (kg)
STANDARD_DEVIATION 17.75 • n=5 Participants
|
|
Duration of Diabetes
|
9.80 years
STANDARD_DEVIATION 6.45 • n=5 Participants
|
9.90 years
STANDARD_DEVIATION 6.51 • n=7 Participants
|
9.85 years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
|
Height
|
165.45 centimeters (cm)
STANDARD_DEVIATION 10.04 • n=5 Participants
|
164.62 centimeters (cm)
STANDARD_DEVIATION 10.11 • n=7 Participants
|
165.03 centimeters (cm)
STANDARD_DEVIATION 10.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.
Outcome measures
| Measure |
Lispro
n=225 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=226 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Baseline
|
8.70 percent of HbA1c
Standard Error 0.06
|
8.69 percent of HbA1c
Standard Error 0.06
|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Change from Baseline
|
-1.46 percent of HbA1c
Standard Error 0.07
|
-1.41 percent of HbA1c
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, 12 Weeks, 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Baseline (n= 225, n= 226)
|
8.70 percent hemoglobin
Standard Error 0.06
|
8.69 percent hemoglobin
Standard Error 0.06
|
|
Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Week 12 HbA1c (n=213, n=220)
|
7.30 percent hemoglobin
Standard Error 0.07
|
7.36 percent hemoglobin
Standard Error 0.07
|
|
Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Week 12 Change from Baseline (n=213, n=220)
|
-1.36 percent hemoglobin
Standard Error 0.07
|
-1.30 percent hemoglobin
Standard Error 0.07
|
|
Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Week 24 HbA1c (n=206, n=218)
|
7.15 percent hemoglobin
Standard Error 0.07
|
7.24 percent hemoglobin
Standard Error 0.07
|
|
Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Week 24 Change from Baseline (n=206, n=218)
|
-1.52 percent hemoglobin
Standard Error 0.07
|
-1.43 percent hemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.
Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.
Outcome measures
| Measure |
Lispro
n=226 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=226 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint
HbA1c <7.0%
|
43.8 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint
HbA1c ≤6.5%
|
24.8 percentage of participants
|
21.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.
Outcome measures
| Measure |
Lispro
n=228 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Glycemic Variability at Endpoint
|
1.01 millimoles per liter (mmol/L)
Standard Deviation 0.72
|
0.94 millimoles per liter (mmol/L)
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Actual measurements and daily mean blood glucose levels at endpoint.
Outcome measures
| Measure |
Lispro
n=226 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=226 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Midday Postprandial Meal
|
9.09 millimoles per liter (mmol/L)
Standard Deviation 2.52
|
9.17 millimoles per liter (mmol/L)
Standard Deviation 2.50
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Morning Pre-Meal
|
6.47 millimoles per liter (mmol/L)
Standard Deviation 1.40
|
6.33 millimoles per liter (mmol/L)
Standard Deviation 1.36
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Morning Postprandial Meal
|
8.64 millimoles per liter (mmol/L)
Standard Deviation 2.48
|
9.00 millimoles per liter (mmol/L)
Standard Deviation 2.55
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Midday Pre-Meal
|
6.93 millimoles per liter (mmol/L)
Standard Deviation 2.11
|
7.16 millimoles per liter (mmol/L)
Standard Deviation 2.07
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Evening Pre-Meal
|
7.50 millimoles per liter (mmol/L)
Standard Deviation 2.06
|
7.54 millimoles per liter (mmol/L)
Standard Deviation 2.02
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual Evening Postprandial Meal
|
9.19 millimoles per liter (mmol/L)
Standard Deviation 2.84
|
9.29 millimoles per liter (mmol/L)
Standard Deviation 2.54
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Actual 0300 Hours
|
6.79 millimoles per liter (mmol/L)
Standard Deviation 2.05
|
7.00 millimoles per liter (mmol/L)
Standard Deviation 2.21
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Daily Mean 7-Point SMBG
|
7.79 millimoles per liter (mmol/L)
Standard Deviation 1.82
|
7.96 millimoles per liter (mmol/L)
Standard Deviation 1.74
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Daily Mean Pre-Meal
|
6.99 millimoles per liter (mmol/L)
Standard Deviation 1.77
|
7.04 millimoles per liter (mmol/L)
Standard Deviation 1.55
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Daily Mean Postprandial Meal
|
8.96 millimoles per liter (mmol/L)
Standard Deviation 2.25
|
9.18 millimoles per liter (mmol/L)
Standard Deviation 2.20
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Daily Mean Morning+Evening Pre-Meal
|
6.99 millimoles per liter (mmol/L)
Standard Deviation 1.51
|
6.93 millimoles per liter (mmol/L)
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value \<2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
All Hypoglycemic Episodes
|
168 participants
|
160 participants
|
|
Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
Nocturnal Hypoglycemic Episodes
|
114 participants
|
87 participants
|
|
Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
Severe Hypoglycemic Episodes
|
9 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value \<2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Hypoglycemic Rate
|
24.16 hypoglycemic event per 1 year
Standard Deviation 28.78
|
22.95 hypoglycemic event per 1 year
Standard Deviation 30.87
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Nocturnal Hypoglycemic Rate
|
6.08 hypoglycemic event per 1 year
Standard Deviation 10.62
|
4.08 hypoglycemic event per 1 year
Standard Deviation 9.40
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Severe Hypoglycemic Rate
|
0.11 hypoglycemic event per 1 year
Standard Deviation 0.58
|
0.02 hypoglycemic event per 1 year
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value \<2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Hypoglycemic Rate
|
1.98 hypoglycemic events per 30 days
Standard Deviation 2.36
|
1.88 hypoglycemic events per 30 days
Standard Deviation 2.54
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Nocturnal Hypoglycemic Rate
|
0.50 hypoglycemic events per 30 days
Standard Deviation 0.87
|
0.34 hypoglycemic events per 30 days
Standard Deviation 0.77
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Severe Hypoglycemic Rate
|
0.01 hypoglycemic events per 30 days
Standard Deviation 0.05
|
0.00 hypoglycemic events per 30 days
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Baseline
|
84.23 kilograms (kg)
Standard Deviation 16.83
|
86.05 kilograms (kg)
Standard Deviation 18.62
|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Change from Baseline
|
1.04 kilograms (kg)
Standard Deviation 3.45
|
1.07 kilograms (kg)
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=228 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Total Daily Insulin Dose (Units) at Endpoint
|
33.28 Units of insulin
Standard Deviation 21.84
|
30.85 Units of insulin
Standard Deviation 20.46
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).
Outcome measures
| Measure |
Lispro
n=229 Participants
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=228 Participants
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
|
0.39 Units of insulin/kilograms (U/kg)
Standard Deviation 0.24
|
0.35 Units of insulin/kilograms (U/kg)
Standard Deviation 0.20
|
Adverse Events
Lispro
Serious events: 4 serious events
Other events: 100 other events
Deaths: 0 deaths
Glargine
Serious events: 10 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lispro
n=229 participants at risk
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 participants at risk
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
Other adverse events
| Measure |
Lispro
n=229 participants at risk
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Glargine
n=229 participants at risk
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/229 • Number of events 3
|
1.3%
3/229 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
9/229 • Number of events 9
|
3.1%
7/229 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
0.87%
2/229 • Number of events 2
|
1.3%
3/229 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
3/229 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/229 • Number of events 1
|
3.5%
8/229 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
4/229 • Number of events 4
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Chest pain
|
1.3%
3/229 • Number of events 3
|
1.7%
4/229 • Number of events 6
|
|
General disorders
Fatigue
|
1.3%
3/229 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
General disorders
Oedema peripheral
|
1.3%
3/229 • Number of events 3
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Pyrexia
|
1.7%
4/229 • Number of events 5
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.7%
4/229 • Number of events 4
|
0.87%
2/229 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/229 • Number of events 1
|
1.7%
4/229 • Number of events 4
|
|
Infections and infestations
Influenza
|
3.5%
8/229 • Number of events 10
|
4.8%
11/229 • Number of events 12
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
10/229 • Number of events 10
|
7.4%
17/229 • Number of events 17
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
3/229 • Number of events 3
|
0.00%
0/229
|
|
Infections and infestations
Tooth infection
|
0.00%
0/229
|
1.3%
3/229 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
8/229 • Number of events 10
|
2.2%
5/229 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
0.87%
2/229 • Number of events 2
|
1.3%
3/229 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
4/229 • Number of events 6
|
2.6%
6/229 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
6/229 • Number of events 6
|
3.5%
8/229 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
3/229 • Number of events 5
|
0.44%
1/229 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
6/229 • Number of events 7
|
3.1%
7/229 • Number of events 7
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/229
|
1.3%
3/229 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.44%
1/229 • Number of events 1
|
2.6%
6/229 • Number of events 6
|
|
Nervous system disorders
Headache
|
6.6%
15/229 • Number of events 25
|
5.2%
12/229 • Number of events 22
|
|
Nervous system disorders
Paraesthesia
|
1.7%
4/229 • Number of events 5
|
0.87%
2/229 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
1.7%
4/229 • Number of events 5
|
2.2%
5/229 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
1.7%
4/229 • Number of events 4
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
4/229 • Number of events 7
|
2.6%
6/229 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.87%
2/229 • Number of events 3
|
1.3%
3/229 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
3/229 • Number of events 3
|
0.00%
0/229
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.44%
1/229 • Number of events 1
|
1.3%
3/229 • Number of events 3
|
|
Vascular disorders
Hypertension
|
2.6%
6/229 • Number of events 8
|
0.87%
2/229 • Number of events 2
|
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