Trial Outcomes & Findings for A Study for Patients With Type 2 Diabetes (NCT NCT01027871)
NCT ID: NCT01027871
Last Updated: 2018-06-08
Results Overview
8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c \[HbA1c\] group); visit; visit and treatment interaction; random effect for participant.
COMPLETED
PHASE2
289 participants
Week 12
2018-06-08
Participant Flow
Participant milestones
| Measure |
Insulin Glargine
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
Participants took both LY2605541 and their pre-study insulin for first several days
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
98
|
98
|
|
Overall Study
Received at Least One Dose of Study Drug
|
93
|
98
|
97
|
|
Overall Study
COMPLETED
|
91
|
85
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
13
|
7
|
Reasons for withdrawal
| Measure |
Insulin Glargine
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
Participants took both LY2605541 and their pre-study insulin for first several days
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
5
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
|
Overall Study
Sponsor Decision
|
0
|
2
|
0
|
|
Overall Study
Discontinued Prior to Treatment
|
0
|
0
|
1
|
Baseline Characteristics
A Study for Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=98 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
|
LY2605541 Algrithm 2
n=97 Participants
Participants took only LY2605541 with first dose doubled
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.74 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
58.57 years
STANDARD_DEVIATION 9.99 • n=7 Participants
|
59.23 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
59.49 years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c \[HbA1c\] group); visit; visit and treatment interaction; random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=89 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=86 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=91 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
|
6.83 millimoles per Liter (mmol/L)
Standard Error 0.22
|
7.15 millimoles per Liter (mmol/L)
Standard Error 0.22
|
6.84 millimoles per Liter (mmol/L)
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=89 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=177 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint
|
-1.77 mmol/Liter
Standard Error 0.26
|
-1.97 mmol/Liter
Standard Error 0.21
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 dose algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=91 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=176 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint
|
-0.64 percentage of glycated hemoglobin
Standard Error 0.08
|
-0.74 percentage of glycated hemoglobin
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Insulin Glargine
n=91 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=183 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint
HbA1c <7.0%
|
48.4 percentage of participants
|
51.9 percentage of participants
|
—
|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint
HbA1c ≤6.5%
|
23.1 percentage of participants
|
29.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia 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 BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter \[mg/dL\]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]).
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=188 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment
HbA1c <7.0%
|
11.96 percentage of participants
|
16.49 percentage of participants
|
—
|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment
HbA1c ≤6.5%
|
6.52 percentage of participants
|
7.98 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=191 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Morning 2-hr postprandial BG
|
9.54 mmol/L
Standard Error 0.31
|
9.11 mmol/L
Standard Error 0.25
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Midday Pre-meal BG
|
7.47 mmol/L
Standard Error 0.28
|
7.23 mmol/L
Standard Error 0.23
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Midday 2-hr postprandial BG
|
9.49 mmol/L
Standard Error 0.28
|
9.22 mmol/L
Standard Error 0.22
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Evening Pre-meal BG
|
7.92 mmol/L
Standard Error 0.28
|
7.80 mmol/L
Standard Error 0.22
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Evening 2-hr postprandial BG
|
9.99 mmol/L
Standard Error 0.30
|
9.74 mmol/L
Standard Error 0.24
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Bed time BG
|
9.44 mmol/L
Standard Error 0.31
|
9.15 mmol/L
Standard Error 0.25
|
—
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
0300 hours BG
|
7.26 mmol/L
Standard Error 0.25
|
7.36 mmol/L
Standard Error 0.20
|
—
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=188 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Daily Basal Insulin Dose at Week 2 and Week 12
Week 2
|
2.45 nanomole per kilogram (nmol/kg)
Standard Error 0.15
|
3.19 nanomole per kilogram (nmol/kg)
Standard Error 0.12
|
—
|
|
Daily Basal Insulin Dose at Week 2 and Week 12
Week 12
|
2.90 nanomole per kilogram (nmol/kg)
Standard Error 0.19
|
4.58 nanomole per kilogram (nmol/kg)
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least one dose of study drug.
Hypoglycemia 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 BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]).
Outcome measures
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=195 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Hypoglycemia From Baseline Through Week 12
|
63.4 percentage of participants
|
54.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least one dose of study drug.
Hypoglycemia 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 BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk\*30.
Outcome measures
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=195 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12
|
1.52 Number of Hypoglycemia episodes/30 days
Standard Deviation 2.08
|
1.34 Number of Hypoglycemia episodes/30 days
Standard Deviation 2.47
|
—
|
SECONDARY outcome
Timeframe: Week 12 and Week 16Population: All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.
Negative is defined as either 'negative' from lab or percent binding \<1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.
Outcome measures
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=98 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=97 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
Week 12 from negative to positive
|
2.4 percentage of participants
|
4.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
Week 12 from positive to negative
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
Week 16 from negative to positive
|
2.4 percentage of participants
|
4.9 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
Week 16 from positive to negative
|
2.4 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week12Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=191 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12
Baseline
|
1.52 nmol/L
Standard Error 0.11
|
1.51 nmol/L
Standard Error 0.09
|
—
|
|
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12
Week 12
|
1.23 nmol/L
Standard Error 0.08
|
1.20 nmol/L
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Participants who took at least one dose of study drug and had measurements at Week 12.
The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.
Outcome measures
| Measure |
Insulin Glargine
n=177 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint
|
4258 picomoles per liter (pMol/L)
Geometric Coefficient of Variation 70.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.
FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=89 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=70 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=78 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
|
-1.82 nmol/L
Standard Error 0.23
|
-2.22 nmol/L
Standard Error 0.24
|
-1.99 nmol/L
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=91 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=69 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=78 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
|
-0.65 percentage of glycated hemoglobin
Standard Error 0.07
|
-0.67 percentage of glycated hemoglobin
Standard Error 0.07
|
-0.83 percentage of glycated hemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Insulin Glargine
n=91 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=73 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=80 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
HbA1c <7.0%
|
48.4 percentage of participants
|
57.5 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
HbA1c ≤6.5%
|
23.1 percentage of participants
|
31.5 percentage of participants
|
26.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia 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 BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]).
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=75 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=83 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
HbA1c <7.0%
|
11.96 percentage of participants
|
21.33 percentage of participants
|
15.66 percentage of participants
|
|
Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
HbA1c ≤6.5%
|
6.52 percentage of participants
|
9.33 percentage of participants
|
7.23 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.
8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=78 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=83 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Midday Pre-meal BG
|
7.29 nmol/L
Standard Error 0.26
|
7.22 nmol/L
Standard Error 0.27
|
6.60 nmol/L
Standard Error 0.26
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
0300 hours BG
|
7.10 nmol/L
Standard Error 0.22
|
7.34 nmol/L
Standard Error 0.24
|
6.82 nmol/L
Standard Error 0.23
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Morning pre-meal BG
|
6.76 nmol/L
Standard Error 0.19
|
7.02 nmol/L
Standard Error 0.21
|
6.62 nmol/L
Standard Error 0.20
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Morning 2-hr postprandial BG
|
9.31 nmol/L
Standard Error 0.27
|
9.05 nmol/L
Standard Error 0.29
|
8.48 nmol/L
Standard Error 0.28
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Midday 2-hr postprandial BG
|
9.36 nmol/L
Standard Error 0.25
|
8.96 nmol/L
Standard Error 0.27
|
9.09 nmol/L
Standard Error 0.26
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Evening Pre-meal BG
|
7.79 nmol/L
Standard Error 0.25
|
7.64 nmol/L
Standard Error 0.27
|
7.64 nmol/L
Standard Error 0.25
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Evening 2-hr postprandial BG
|
9.64 nmol/L
Standard Error 0.26
|
9.14 nmol/L
Standard Error 0.28
|
9.22 nmol/L
Standard Error 0.27
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Bed time BG
|
9.13 nmol/L
Standard Error 0.27
|
8.86 nmol/L
Standard Error 0.29
|
8.43 nmol/L
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.
LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=76 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=81 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Week 2
|
2.62 nmol/kg
Standard Error 0.13
|
3.23 nmol/kg
Standard Error 0.13
|
3.64 nmol/kg
Standard Error 0.13
|
|
Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Week 12
|
3.15 nmol/kg
Standard Error 0.16
|
4.58 nmol/kg
Standard Error 0.17
|
5.26 nmol/kg
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.
Hypoglycemia 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 BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]).
Outcome measures
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=80 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=83 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
|
63.4 percentage of participants
|
47.5 percentage of participants
|
54.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.
Hypoglycemia 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 BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk\*30.
Outcome measures
| Measure |
Insulin Glargine
n=93 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=80 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=83 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
|
1.52 Number of Hypoglycemia episodes/30 days
Standard Deviation 2.08
|
1.25 Number of Hypoglycemia episodes/30 days
Standard Deviation 2.27
|
1.27 Number of Hypoglycemia episodes/30 days
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.
Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.
Outcome measures
| Measure |
Insulin Glargine
n=92 Participants
Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 1
n=77 Participants
Participants took both LY2605541 and their pre-study insulin for first several days
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Algorithm 2
n=83 Participants
Participants took only LY2605541 with first dose doubled
Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Baseline
|
1.43 nmol/L
Standard Error 0.07
|
1.40 nmol/L
Standard Error 0.08
|
1.42 nmol/L
Standard Error 0.07
|
|
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Week 12
|
1.17 nmol/L
Standard Error 0.07
|
1.16 nmol/L
Standard Error 0.08
|
1.07 nmol/L
Standard Error 0.07
|
Adverse Events
LY2605541 Dosing Algorithm 1
LY2605541 Dosing Algorithm 2
Insulin Glargine
Serious adverse events
| Measure |
LY2605541 Dosing Algorithm 1
n=98 participants at risk
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Dosing Algorithm 2
n=98 participants at risk
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
Insulin Glargine
n=93 participants at risk
Subcutaneous injection of insulin Glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
1.0%
1/98 • Number of events 1
|
1.0%
1/98 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/98
|
0.00%
0/98
|
1.1%
1/93 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • Number of events 1
|
1.0%
1/98 • Number of events 1
|
0.00%
0/93
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/98 • Number of events 1
|
0.00%
0/98
|
0.00%
0/93
|
|
Injury, poisoning and procedural complications
Foreign body
|
1.0%
1/98 • Number of events 1
|
0.00%
0/98
|
0.00%
0/93
|
Other adverse events
| Measure |
LY2605541 Dosing Algorithm 1
n=98 participants at risk
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
LY2605541 Dosing Algorithm 2
n=98 participants at risk
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
|
Insulin Glargine
n=93 participants at risk
Subcutaneous injection of insulin Glargine every morning with dose titration based on blood glucose measures for 12 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
2/98 • Number of events 2
|
0.00%
0/98
|
0.00%
0/93
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
|
Eye disorders
Eye pain
|
0.00%
0/98
|
3.1%
3/98 • Number of events 3
|
0.00%
0/93
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/98
|
0.00%
0/98
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/98 • Number of events 1
|
0.00%
0/98
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/98 • Number of events 1
|
2.0%
2/98 • Number of events 2
|
3.2%
3/93 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
3/98 • Number of events 3
|
3.1%
3/98 • Number of events 3
|
3.2%
3/93 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/98 • Number of events 2
|
1.0%
1/98 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/98
|
1.0%
1/98 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
|
General disorders
Asthenia
|
2.0%
2/98 • Number of events 2
|
0.00%
0/98
|
0.00%
0/93
|
|
General disorders
Fatigue
|
2.0%
2/98 • Number of events 2
|
0.00%
0/98
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.0%
1/98 • Number of events 1
|
1.0%
1/98 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
|
Infections and infestations
Influenza
|
3.1%
3/98 • Number of events 3
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
3/98 • Number of events 3
|
6.1%
6/98 • Number of events 6
|
5.4%
5/93 • Number of events 6
|
|
Infections and infestations
Sinusitis
|
1.0%
1/98 • Number of events 1
|
0.00%
0/98
|
2.2%
2/93 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/98 • Number of events 2
|
3.1%
3/98 • Number of events 3
|
3.2%
3/93 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98
|
3.1%
3/98 • Number of events 3
|
0.00%
0/93
|
|
Infections and infestations
Viral infection
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/98 • Number of events 3
|
0.00%
0/98
|
0.00%
0/93
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/98
|
0.00%
0/98
|
2.2%
2/93 • Number of events 2
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
2.0%
2/98 • Number of events 2
|
4.1%
4/98 • Number of events 4
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/98
|
2.0%
2/98 • Number of events 3
|
3.2%
3/93 • Number of events 3
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.0%
2/98 • Number of events 2
|
1.0%
1/98 • Number of events 1
|
0.00%
0/93
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
|
Metabolism and nutrition disorders
Underweight
|
1.0%
1/98 • Number of events 1
|
4.1%
4/98 • Number of events 4
|
0.00%
0/93
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/98 • Number of events 2
|
2.0%
2/98 • Number of events 3
|
4.3%
4/93 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/98 • Number of events 1
|
3.1%
3/98 • Number of events 3
|
0.00%
0/93
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
4/98 • Number of events 4
|
1.0%
1/98 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.0%
2/98 • Number of events 2
|
0.00%
0/98
|
0.00%
0/93
|
|
Nervous system disorders
Dizziness
|
3.1%
3/98 • Number of events 3
|
0.00%
0/98
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.1%
4/98 • Number of events 4
|
2.0%
2/98 • Number of events 2
|
4.3%
4/93 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/98 • Number of events 6
|
0.00%
0/98
|
0.00%
0/93
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/98 • Number of events 1
|
1.0%
1/98 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98
|
0.00%
0/98
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
|
Vascular disorders
Hypertension
|
0.00%
0/98
|
2.0%
2/98 • Number of events 2
|
0.00%
0/93
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60