Trial Outcomes & Findings for A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus (NCT NCT01175811)
NCT ID: NCT01175811
Last Updated: 2013-12-18
Results Overview
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
402 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2013-12-18
Participant Flow
Participant milestones
| Measure |
Premixed Insulin
Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
203
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
197
|
202
|
|
Overall Study
COMPLETED
|
183
|
189
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Premixed Insulin
Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Entry criteria not met
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
Baseline Characteristics
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Premixed Insulin
n=199 Participants
Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=203 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.0 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 9.05 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
199 participants
n=5 Participants
|
203 participants
n=7 Participants
|
402 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
China
|
157 participants
n=5 Participants
|
158 participants
n=7 Participants
|
315 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
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
|
-1.05 percent HbA1c
Interval -1.19 to -0.92
|
-1.06 percent HbA1c
Interval -1.19 to -0.93
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Change in HbA1c From Baseline to 12 Week Endpoint
|
-0.96 percent HbA1c
Interval -1.1 to -0.82
|
-0.96 percent HbA1c
Interval -1.1 to -0.82
|
SECONDARY outcome
Timeframe: 12 weeks, 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.
The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (\<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
<=6.5 Percent HbA1c at 12 weeks
|
6.1 Percentage of participants
|
8.9 Percentage of participants
|
|
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
<=7.0 Percent HbA1c at 12 weeks
|
26.4 Percentage of participants
|
27.7 Percentage of participants
|
|
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
<=6.5 Percent HbA1c at 24 weeks
|
9.1 Percentage of participants
|
11.9 Percentage of participants
|
|
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
<=7.0 Percent HbA1c at 24 weeks
|
29.9 Percentage of participants
|
34.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour \[3 am\]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning Pre-meal (Week 0) (n=195, 201)
|
155.0 milligrams per deciliter (mg/dL)
Standard Deviation 34.89
|
157.7 milligrams per deciliter (mg/dL)
Standard Deviation 38.81
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning Pre-meal (Week 12) (n=187, 191)
|
141.8 milligrams per deciliter (mg/dL)
Standard Deviation 30.78
|
136.5 milligrams per deciliter (mg/dL)
Standard Deviation 31.44
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning Pre-meal (Week 24) (n=177, 186)
|
137.4 milligrams per deciliter (mg/dL)
Standard Deviation 24.96
|
132.4 milligrams per deciliter (mg/dL)
Standard Deviation 25.17
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning 2 hours Post-meal (Week 0) (n=194, 201)
|
207.1 milligrams per deciliter (mg/dL)
Standard Deviation 54.74
|
213.6 milligrams per deciliter (mg/dL)
Standard Deviation 53.95
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning 2 hours Post-meal (Week 12) (n=187, 190)
|
179.6 milligrams per deciliter (mg/dL)
Standard Deviation 46.17
|
176.5 milligrams per deciliter (mg/dL)
Standard Deviation 43.69
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Morning 2 hours Post-meal (Week 24) (n=176, 184)
|
169.7 milligrams per deciliter (mg/dL)
Standard Deviation 39.04
|
165.8 milligrams per deciliter (mg/dL)
Standard Deviation 35.77
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday Pre-meal (Week 0) (n=195, 200)
|
160.7 milligrams per deciliter (mg/dL)
Standard Deviation 47.89
|
164.9 milligrams per deciliter (mg/dL)
Standard Deviation 48.71
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday Pre-meal (Week 12) (n=187, 190)
|
142.5 milligrams per deciliter (mg/dL)
Standard Deviation 37.27
|
149.4 milligrams per deciliter (mg/dL)
Standard Deviation 41.58
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday Pre-meal (Week 24) (n=177, 186)
|
139.5 milligrams per deciliter (mg/dL)
Standard Deviation 31.05
|
142.1 milligrams per deciliter (mg/dL)
Standard Deviation 32.73
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday 2 hours Post-meal (Week 0) (n=194, 201)
|
219.7 milligrams per deciliter (mg/dL)
Standard Deviation 54.03
|
227.5 milligrams per deciliter (mg/dL)
Standard Deviation 54.56
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday 2 hours Post-meal (Week 12) (n=186, 189)
|
162.5 milligrams per deciliter (mg/dL)
Standard Deviation 41.53
|
177.2 milligrams per deciliter (mg/dL)
Standard Deviation 44.53
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Midday 2 hours Post-meal (Week 24) (n=175, 184)
|
161.9 milligrams per deciliter (mg/dL)
Standard Deviation 38.66
|
171.1 milligrams per deciliter (mg/dL)
Standard Deviation 39.33
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening Pre-meal (Week 0) (n=195, 200)
|
186.6 milligrams per deciliter (mg/dL)
Standard Deviation 44.97
|
190.0 milligrams per deciliter (mg/dL)
Standard Deviation 53.41
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening Pre-meal (Week 12) (n=187, 190)
|
148.1 milligrams per deciliter (mg/dL)
Standard Deviation 33.74
|
157.6 milligrams per deciliter (mg/dL)
Standard Deviation 42.00
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening Pre-meal (Week 24) (n=177, 186)
|
145.0 milligrams per deciliter (mg/dL)
Standard Deviation 30.67
|
151.1 milligrams per deciliter (mg/dL)
Standard Deviation 33.36
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening 2 hours Post-meal (Week 0) (n=194, 201)
|
204.8 milligrams per deciliter (mg/dL)
Standard Deviation 54.31
|
209.9 milligrams per deciliter (mg/dL)
Standard Deviation 58.59
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening 2 hours Post-meal (Week 12) (n=186, 190)
|
177.1 milligrams per deciliter (mg/dL)
Standard Deviation 45.29
|
176.2 milligrams per deciliter (mg/dL)
Standard Deviation 40.55
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Evening 2 hours Post-meal (Week 24)(n=176, 185)
|
172.0 milligrams per deciliter (mg/dL)
Standard Deviation 38.77
|
165.6 milligrams per deciliter (mg/dL)
Standard Deviation 38.66
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
0300 Hours (3 am) (Week 0) (n=185, 193)
|
175.9 milligrams per deciliter (mg/dL)
Standard Deviation 51.97
|
180.0 milligrams per deciliter (mg/dL)
Standard Deviation 54.35
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
0300 Hours (3 am) (Week 12) (n=177, 185)
|
150.3 milligrams per deciliter (mg/dL)
Standard Deviation 39.41
|
163.6 milligrams per deciliter (mg/dL)
Standard Deviation 42.42
|
|
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
0300 Hours (3 am) (Week 24) (n=171, 179)
|
145.1 milligrams per deciliter (mg/dL)
Standard Deviation 31.45
|
155.8 milligrams per deciliter (mg/dL)
Standard Deviation 34.36
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Daily Dose of Insulin: Total, Basal, and Prandial
Total Daily Dose
|
52.9 International Units (IU)
Standard Deviation 19.72
|
54.0 International Units (IU)
Standard Deviation 19.00
|
|
Daily Dose of Insulin: Total, Basal, and Prandial
Daily Insulin Dose Basal
|
31.539 International Units (IU)
Standard Deviation 11.9288
|
24.717 International Units (IU)
Standard Deviation 9.9304
|
|
Daily Dose of Insulin: Total, Basal, and Prandial
Daily Insulin Dose Bolus (prandial)
|
21.385 International Units (IU)
Standard Deviation 7.8823
|
29.269 International Units (IU)
Standard Deviation 10.8353
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Change at 12 weeks
|
0.26 kilogram per square meter (kg/m^2)
Interval 0.16 to 0.37
|
0.20 kilogram per square meter (kg/m^2)
Interval 0.1 to 0.3
|
|
Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Change at 24 weeks
|
0.31 kilogram per square meter (kg/m^2)
Interval 0.19 to 0.42
|
0.29 kilogram per square meter (kg/m^2)
Interval 0.18 to 0.4
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Total Daily Dose
|
0.738 International Units per kilogram (IU/kg)
Standard Deviation 0.2477
|
0.760 International Units per kilogram (IU/kg)
Standard Deviation 0.2694
|
|
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Daily Insulin Dose Basal
|
0.440 International Units per kilogram (IU/kg)
Standard Deviation 0.1498
|
0.348 International Units per kilogram (IU/kg)
Standard Deviation 0.1390
|
|
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Daily Insulin Dose Bolus (prandial)
|
0.298 International Units per kilogram (IU/kg)
Standard Deviation 0.0994
|
0.412 International Units per kilogram (IU/kg)
Standard Deviation 0.1542
|
SECONDARY outcome
Timeframe: baseline through 24 weeksPopulation: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Episodes (Incidence)
|
54.8 percentage of participants
|
55.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline through 24 weeksPopulation: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
The Rate of Hypoglycemic Episodes
|
0.468 hypoglycemic episode/30 days/participant
Standard Error 1.0417
|
0.409 hypoglycemic episode/30 days/participant
Standard Error 0.6668
|
SECONDARY outcome
Timeframe: baseline through 24 weeksPopulation: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.
Outcome measures
| Measure |
Premixed Insulin
n=197 Participants
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 Participants
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Percentage of Participants Experiencing a Severe Hypoglycemic Episode
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Premixed Insulin
Serious events: 13 serious events
Other events: 60 other events
Deaths: 0 deaths
Basal-Bolus
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Premixed Insulin
n=197 participants at risk
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 participants at risk
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Cardiac disorders
Cardiac failure chronic
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Cellulitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accident
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Patella fracture
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Vascular disorders
Diabetic vascular disorder
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
Other adverse events
| Measure |
Premixed Insulin
n=197 participants at risk
Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks
|
Basal-Bolus
n=202 participants at risk
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Cardiac disorders
Angina pectoris
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Cardiac disorders
Extrasystoles
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Eye disorders
Cataract
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Eye disorders
Conjunctivitis allergic
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Eye disorders
Diabetic retinopathy
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Eye disorders
Eye pain
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/197
|
0.99%
2/202 • Number of events 2
|
|
Eye disorders
Vitreous haemorrhage
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
2/197 • Number of events 2
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
1/197 • Number of events 1
|
2.5%
5/202 • Number of events 6
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.51%
1/197 • Number of events 6
|
0.00%
0/202
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Toothache
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
General disorders
Chest discomfort
|
1.5%
3/197 • Number of events 3
|
0.00%
0/202
|
|
General disorders
Oedema
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
General disorders
Pain
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
General disorders
Pyrexia
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Acute tonsillitis
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Cervicitis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Cystitis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Infections and infestations
Localised infection
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Lung infection
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
15/197 • Number of events 16
|
8.4%
17/202 • Number of events 19
|
|
Infections and infestations
Otitis media
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Periodontitis
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Infections and infestations
Pharyngitis
|
1.5%
3/197 • Number of events 3
|
0.99%
2/202 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
7/197 • Number of events 10
|
5.0%
10/202 • Number of events 12
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/197 • Number of events 1
|
1.5%
3/202 • Number of events 3
|
|
Infections and infestations
Vaginal infection
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 2
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Open wound
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Investigations
Alanine aminotransferase increased
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Investigations
Blood potassium decreased
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Investigations
Weight decreased
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Investigations
Weight increased
|
1.5%
3/197 • Number of events 3
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
1/197 • Number of events 1
|
0.99%
2/202 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.0%
4/197 • Number of events 7
|
3.0%
6/202 • Number of events 6
|
|
Nervous system disorders
Headache
|
1.0%
2/197 • Number of events 2
|
0.99%
2/202 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
Poor quality sleep
|
0.51%
1/197 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.5%
3/197 • Number of events 3
|
0.50%
1/202 • Number of events 1
|
|
Psychiatric disorders
Nervousness
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
3/197 • Number of events 3
|
0.50%
1/202 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
1/197 • Number of events 1
|
0.00%
0/202
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/197
|
0.99%
2/202 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/197
|
0.50%
1/202 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.0%
2/197 • Number of events 2
|
0.00%
0/202
|
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