Trial Outcomes & Findings for Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast (NCT NCT00664534)
NCT ID: NCT00664534
Last Updated: 2011-12-13
Results Overview
Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
344 participants
Primary outcome timeframe
48 weeks
Results posted on
2011-12-13
Participant Flow
Participant milestones
| Measure |
Glargine
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
171
|
|
Overall Study
COMPLETED
|
132
|
138
|
|
Overall Study
NOT COMPLETED
|
41
|
33
|
Reasons for withdrawal
| Measure |
Glargine
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
|
Overall Study
Protocol Violation
|
10
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Physician Decision
|
8
|
0
|
|
Overall Study
Sponsor decision
|
8
|
6
|
Baseline Characteristics
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Baseline characteristics by cohort
| Measure |
Glargine
n=173 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=171 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.24 years
STANDARD_DEVIATION 8.621 • n=5 Participants
|
54.33 years
STANDARD_DEVIATION 8.944 • n=7 Participants
|
54.29 years
STANDARD_DEVIATION 8.770 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
97 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
38 participants
n=5 Participants
|
33 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
India
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
9.07 percent glycosylated hemoglobin
STANDARD_DEVIATION 0.988 • n=5 Participants
|
8.98 percent glycosylated hemoglobin
STANDARD_DEVIATION 0.945 • n=7 Participants
|
9.02 percent glycosylated hemoglobin
STANDARD_DEVIATION 0.966 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: PP Population=All participants who were randomized and met following criteria during study: * no violations of Inclusion/Exclusion Criteria * no early study discontinuation * compliant with treatment * received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for \>14 consecutive days.
Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.
Outcome measures
| Measure |
Glargine
n=98 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=108 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
|
7.55 percent glycosylated hemoglobin
Interval 7.27 to 7.82
|
7.40 percent glycosylated hemoglobin
Interval 7.15 to 7.65
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.
Insulin Regimens: Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro.
Outcome measures
| Measure |
Glargine
n=130 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=137 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
MM before noon
|
0 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
LM before PM
|
0 percentage of participants
|
33 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
MM before noon+LM before PM
|
0 percentage of participants
|
42 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
LM before AM+MM before noon+LM before PM
|
0 percentage of participants
|
36 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
MM before AM+MM before noon+LM before PM
|
0 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
Glargine QD
|
59 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
Glargine QD+1 Lispro (noon or PM)
|
27 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
Glargine QD+2 Lispro (noon and PM)
|
30 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
Glargine QD+3 Lispro
|
14 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Using Each Possible Final Insulin Regimen
Other (not specified)
|
0 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks, and 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit\*treatment in Full Analysis Set (FAS) Population.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=158 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
HbA1c Over Time
16 weeks (n=142,n=140)
|
7.57 percent glycosylated hemoglobin
Interval 7.38 to 7.75
|
7.62 percent glycosylated hemoglobin
Interval 7.43 to 7.81
|
|
HbA1c Over Time
32 weeks (n=119, n=121)
|
7.43 percent glycosylated hemoglobin
Interval 7.22 to 7.63
|
7.46 percent glycosylated hemoglobin
Interval 7.26 to 7.67
|
|
HbA1c Over Time
48 weeks (n=115,n=125)
|
7.40 percent glycosylated hemoglobin
Interval 7.2 to 7.61
|
7.33 percent glycosylated hemoglobin
Interval 7.13 to 7.53
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks and 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=158 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 16 HbA1c <=7.0% (n=157, n=155)
|
24.2 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 16 HbA1c <=6.5% (n=157, n=155)
|
14.6 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 32 HbA1c <=7.0% (n=137, n=141)
|
32.1 percentage of participants
|
37.6 percentage of participants
|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 32 HbA1c <=6.5% (n=137, n=141)
|
19.0 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 48 HbA1c <=7.0% (n=130, n=137)
|
36.2 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Week 48 HbA1c <=6.5% (n=130, n=137)
|
18.5 percentage of participants
|
24.8 percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks and 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=158 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 After Dinner (n=128, n=131)
|
8.64 millimoles per Liter (mmol/L)
Standard Error 0.23
|
8.50 millimoles per Liter (mmol/L)
Standard Error 0.23
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 Before Breakfast (n=142, n=145)
|
6.94 millimoles per Liter (mmol/L)
Standard Error 0.17
|
7.36 millimoles per Liter (mmol/L)
Standard Error 0.17
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 Before Breakfast (n=126, n=130)
|
6.65 millimoles per Liter (mmol/L)
Standard Error 0.14
|
7.20 millimoles per Liter (mmol/L)
Standard Error 0.14
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 Before Breakfast (n=123, n=130)
|
6.79 millimoles per Liter (mmol/L)
Standard Error 0.15
|
6.94 millimoles per Liter (mmol/L)
Standard Error 0.15
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 After Breakfast (n=136, n=138)
|
9.12 millimoles per Liter (mmol/L)
Standard Error 0.25
|
9.92 millimoles per Liter (mmol/L)
Standard Error 0.25
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 After Breakfast (n=123, n=127)
|
8.65 millimoles per Liter (mmol/L)
Standard Error 0.24
|
9.16 millimoles per Liter (mmol/L)
Standard Error 0.23
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 After Breakfast (n=120, n=129)
|
8.88 millimoles per Liter (mmol/L)
Standard Error 0.23
|
8.94 millimoles per Liter (mmol/L)
Standard Error 0.22
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 Before Lunch (n=143, n=145)
|
7.33 millimoles per Liter (mmol/L)
Standard Error 0.21
|
7.66 millimoles per Liter (mmol/L)
Standard Error 0.21
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 Before Lunch (n=128, n=132)
|
7.00 millimoles per Liter (mmol/L)
Standard Error 0.19
|
7.25 millimoles per Liter (mmol/L)
Standard Error 0.19
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 Before Lunch (n=121, n=129)
|
7.14 millimoles per Liter (mmol/L)
Standard Error 0.20
|
6.86 millimoles per Liter (mmol/L)
Standard Error 0.19
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 After Lunch (n=138, n=140)
|
9.32 millimoles per Liter (mmol/L)
Standard Error 0.25
|
9.37 millimoles per Liter (mmol/L)
Standard Error 0.25
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 After Lunch (n=127, n=130)
|
8.34 millimoles per Liter (mmol/L)
Standard Error 0.23
|
8.69 millimoles per Liter (mmol/L)
Standard Error 0.22
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 After Lunch (n=120, n=126)
|
8.58 millimoles per Liter (mmol/L)
Standard Error 0.24
|
8.34 millimoles per Liter (mmol/L)
Standard Error 0.23
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 Before Dinner (n=143, n=145)
|
7.84 millimoles per Liter (mmol/L)
Standard Error 0.21
|
7.92 millimoles per Liter (mmol/L)
Standard Error 0.21
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 Before Dinner (n=129, n=132)
|
7.31 millimoles per Liter (mmol/L)
Standard Error 0.19
|
7.39 millimoles per Liter (mmol/L)
Standard Error 0.18
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 Before Dinner (n=120, n=129)
|
7.55 millimoles per Liter (mmol/L)
Standard Error 0.21
|
7.19 millimoles per Liter (mmol/L)
Standard Error 0.20
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 After Dinner (n=140, n=141)
|
9.68 millimoles per Liter (mmol/L)
Standard Error 0.26
|
9.03 millimoles per Liter (mmol/L)
Standard Error 0.26
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 After Dinner (n=120, n=126)
|
8.87 millimoles per Liter (mmol/L)
Standard Error 0.22
|
8.09 millimoles per Liter (mmol/L)
Standard Error 0.21
|
|
7-point Self-monitored Blood Glucose Profiles
Week 16 at 0300 Hours (n=114, n=120)
|
7.34 millimoles per Liter (mmol/L)
Standard Error 0.33
|
7.22 millimoles per Liter (mmol/L)
Standard Error 0.31
|
|
7-point Self-monitored Blood Glucose Profiles
Week 32 at 0300 Hours (n=105, n=106)
|
6.94 millimoles per Liter (mmol/L)
Standard Error 0.32
|
6.80 millimoles per Liter (mmol/L)
Standard Error 0.31
|
|
7-point Self-monitored Blood Glucose Profiles
Week 48 at 0300 Hours (n=104, n=107)
|
6.94 millimoles per Liter (mmol/L)
Standard Error 0.32
|
6.57 millimoles per Liter (mmol/L)
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks, 32 weeks and 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=158 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Mean Postprandial Blood Glucose Values
Baseline (N=160, N=158)
|
6.25 microgram per milliliter (µg/mL)
Standard Deviation 5.804
|
5.69 microgram per milliliter (µg/mL)
Standard Deviation 4.426
|
|
Mean Postprandial Blood Glucose Values
Week 16 (N=143, N=141)
|
9.69 microgram per milliliter (µg/mL)
Standard Deviation 6.161
|
9.52 microgram per milliliter (µg/mL)
Standard Deviation 5.767
|
|
Mean Postprandial Blood Glucose Values
Week 32 (N=125, N=123)
|
10.54 microgram per milliliter (µg/mL)
Standard Deviation 7.098
|
10.81 microgram per milliliter (µg/mL)
Standard Deviation 6.824
|
|
Mean Postprandial Blood Glucose Values
Week 48 (N=119, N=125)
|
10.90 microgram per milliliter (µg/mL)
Standard Deviation 6.661
|
11.41 microgram per milliliter (µg/mL)
Standard Deviation 7.344
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks and 48 weeksPopulation: Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
Outcome measures
| Measure |
Glargine
n=163 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=158 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 32 Basal Insulin (N=135, N=140)
|
30.05 International Units per day (IU/day)
Standard Deviation 16.211
|
25.06 International Units per day (IU/day)
Standard Deviation 15.763
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 48 Basal Insulin (N=130, N=137)
|
31.52 International Units per day (IU/day)
Standard Deviation 17.194
|
30.12 International Units per day (IU/day)
Standard Deviation 18.612
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 32 Total Daily Insulin (N=135, N=140)
|
40.80 International Units per day (IU/day)
Standard Deviation 27.037
|
38.45 International Units per day (IU/day)
Standard Deviation 23.876
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 48 Total Daily Insulin (N=130, N=137)
|
46.45 International Units per day (IU/day)
Standard Deviation 31.402
|
46.20 International Units per day (IU/day)
Standard Deviation 28.396
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 16 Basal Insulin (N=156, N=155)
|
25.53 International Units per day (IU/day)
Standard Deviation 13.239
|
17.97 International Units per day (IU/day)
Standard Deviation 10.636
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 16 Prandial Insulin (N=156, N=155)
|
4.41 International Units per day (IU/day)
Standard Deviation 9.181
|
8.97 International Units per day (IU/day)
Standard Deviation 5.472
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 32 Prandial Insulin (N=135, N=140)
|
10.75 International Units per day (IU/day)
Standard Deviation 14.901
|
13.39 International Units per day (IU/day)
Standard Deviation 8.599
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 48 Prandial Insulin (N=130, N=137)
|
14.94 International Units per day (IU/day)
Standard Deviation 19.082
|
16.07 International Units per day (IU/day)
Standard Deviation 10.280
|
|
Mean Daily Total, Basal and Prandial Insulin Dose
Week 16 Total Daily Insulin (N=156, N=155)
|
29.94 International Units per day (IU/day)
Standard Deviation 18.523
|
26.94 International Units per day (IU/day)
Standard Deviation 15.398
|
SECONDARY outcome
Timeframe: baseline, 48 weeksPopulation: Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.
Outcome measures
| Measure |
Glargine
n=132 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=138 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Body Weight Change From Baseline to Endpoint
|
2.70 kilograms (kg)
Interval 2.09 to 3.31
|
2.61 kilograms (kg)
Interval 2.01 to 3.21
|
SECONDARY outcome
Timeframe: Baseline to 48 weeksPopulation: Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.
Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).
Outcome measures
| Measure |
Glargine
n=173 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=169 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Incidence of All Self-reported Hypoglycemic Episodes
|
60.1 percentage of participants
|
64.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 48 weeksPopulation: Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.
The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).
Outcome measures
| Measure |
Glargine
n=168 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=165 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Rate Per 30 Days of All Self-reported Hypoglycemic Episodes
|
0.67 episodes per 30 days
Standard Deviation 1.106
|
0.79 episodes per 30 days
Standard Deviation 1.587
|
SECONDARY outcome
Timeframe: Baseline to 48 weeksPopulation: Safety Set Population: All participants who received at least one dose of study drug during the treatment period.
A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module. TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline.
Outcome measures
| Measure |
Glargine
n=173 Participants
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
|
Premix Insulin Lispro
n=169 Participants
Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
|
|---|---|---|
|
Number of Participants With Adverse Events
SAE
|
3 participants
|
7 participants
|
|
Number of Participants With Adverse Events
TEAE
|
53 participants
|
52 participants
|
Adverse Events
Premix Insulin Lispro
Serious events: 7 serious events
Other events: 52 other events
Deaths: 0 deaths
Glargine
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Premix Insulin Lispro
n=169 participants at risk
Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
|
Glargine
n=173 participants at risk
Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
|
Cardiac disorders
Atrioventricular block
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/169
|
0.58%
1/173 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
|
Infections and infestations
Urosepsis
|
0.59%
1/169 • Number of events 1
|
0.58%
1/173 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/169
|
0.58%
1/173 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
|
Surgical and medical procedures
Amputation
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.59%
1/169 • Number of events 1
|
0.00%
0/173
|
Other adverse events
| Measure |
Premix Insulin Lispro
n=169 participants at risk
Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
|
Glargine
n=173 participants at risk
Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
1.2%
2/169 • Number of events 2
|
0.00%
0/173
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
3/169 • Number of events 3
|
1.7%
3/173 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
4/169 • Number of events 4
|
5.2%
9/173 • Number of events 9
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
1/169 • Number of events 1
|
2.3%
4/173 • Number of events 4
|
|
General disorders
Asthenia
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
General disorders
Oedema peripheral
|
1.8%
3/169 • Number of events 3
|
0.58%
1/173 • Number of events 1
|
|
General disorders
Pain
|
0.59%
1/169 • Number of events 1
|
1.2%
2/173 • Number of events 2
|
|
General disorders
Pyrexia
|
3.6%
6/169 • Number of events 6
|
4.0%
7/173 • Number of events 8
|
|
Infections and infestations
Furuncle
|
0.59%
1/169 • Number of events 1
|
1.7%
3/173 • Number of events 3
|
|
Infections and infestations
Influenza
|
2.4%
4/169 • Number of events 4
|
0.58%
1/173 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
3/169 • Number of events 3
|
3.5%
6/173 • Number of events 6
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection viral
|
0.59%
1/169 • Number of events 1
|
1.2%
2/173 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/169 • Number of events 2
|
5.2%
9/173 • Number of events 9
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/169 • Number of events 3
|
0.58%
1/173 • Number of events 1
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
2/169 • Number of events 2
|
1.7%
3/173 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
3/169 • Number of events 3
|
3.5%
6/173 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.59%
1/169 • Number of events 1
|
1.2%
2/173 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 2
|
|
Nervous system disorders
Diabetic neuropathy
|
1.2%
2/169 • Number of events 2
|
1.2%
2/173 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.59%
1/169 • Number of events 1
|
1.2%
2/173 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.4%
4/169 • Number of events 5
|
6.4%
11/173 • Number of events 11
|
|
Nervous system disorders
Neuropathy peripheral
|
3.0%
5/169 • Number of events 5
|
2.3%
4/173 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
0.59%
1/169 • Number of events 1
|
1.2%
2/173 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Psychiatric disorders
Depression
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
3/169 • Number of events 3
|
4.6%
8/173 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
2/169 • Number of events 2
|
0.00%
0/173
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/169
|
1.2%
2/173 • Number of events 2
|
|
Vascular disorders
Hypertension
|
1.2%
2/169 • Number of events 2
|
0.58%
1/173 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/169
|
1.2%
2/173 • 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