Trial Outcomes & Findings for A Study in Adults With Type 2 Diabetes (NCT NCT01421459)
NCT ID: NCT01421459
Last Updated: 2014-12-18
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
759 participants
Primary outcome timeframe
Baseline, Endpoint (up to 24 weeks)
Results posted on
2014-12-18
Participant Flow
Participant milestones
| Measure |
LY2963016 + OAMs
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
379
|
380
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
376
|
380
|
|
Overall Study
COMPLETED
|
334
|
328
|
|
Overall Study
NOT COMPLETED
|
45
|
52
|
Reasons for withdrawal
| Measure |
LY2963016 + OAMs
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
10
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
|
Overall Study
Physician Decision
|
9
|
9
|
|
Overall Study
Protocol Violation
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
16
|
Baseline Characteristics
A Study in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
LY2963016 + OAMs
n=376 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=380 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
Total
n=756 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.98 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
58.67 years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
58.82 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
106 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
244 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
302 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
593 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
39 participants
n=5 Participants
|
31 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
171 participants
n=5 Participants
|
184 participants
n=7 Participants
|
355 participants
n=5 Participants
|
|
Baseline Hemoglobin A1c (HbA1c)
|
8.34 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.09 • n=5 Participants
|
8.31 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.06 • n=7 Participants
|
8.33 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.08 • n=5 Participants
|
|
Sulfonylurea Use
Yes, did use sulfonylurea
|
315 participants
n=5 Participants
|
315 participants
n=7 Participants
|
630 participants
n=5 Participants
|
|
Sulfonylurea Use
No, did not use sulfonylurea
|
61 participants
n=5 Participants
|
65 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Time of Basal Insulin Injection
Daytime
|
187 participants
n=5 Participants
|
188 participants
n=7 Participants
|
375 participants
n=5 Participants
|
|
Time of Basal Insulin Injection
Evening/Bedtime
|
189 participants
n=5 Participants
|
192 participants
n=7 Participants
|
381 participants
n=5 Participants
|
|
Body Weight
|
90.35 kilograms (kg)
STANDARD_DEVIATION 20.02 • n=5 Participants
|
89.83 kilograms (kg)
STANDARD_DEVIATION 19.25 • n=7 Participants
|
90.09 kilograms (kg)
STANDARD_DEVIATION 19.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=369 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=375 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
|
-1.286 percentage of glycosylated hemoglobin
Standard Error 0.06
|
-1.338 percentage of glycosylated hemoglobin
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).
Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=14 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=6 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Change From Baseline in Insulin Antibody Levels
Change at 4 weeks (n=10, 3)
|
-1.07 percentage of insulin antibody binding
Standard Error 1.47
|
-3.25 percentage of insulin antibody binding
Standard Error 2.79
|
|
Change From Baseline in Insulin Antibody Levels
Change at 12 weeks (n=9, 5)
|
-1.57 percentage of insulin antibody binding
Standard Error 1.14
|
-4.39 percentage of insulin antibody binding
Standard Error 1.54
|
|
Change From Baseline in Insulin Antibody Levels
Change at 24 weeks (n=10, 2)
|
-2.61 percentage of insulin antibody binding
Standard Error 0.60
|
-3.21 percentage of insulin antibody binding
Standard Error 1.35
|
|
Change From Baseline in Insulin Antibody Levels
Change at Endpoint, up to 24 weeks (n=14, 6)
|
-2.49 percentage of insulin antibody binding
Standard Error 0.39
|
-3.11 percentage of insulin antibody binding
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeksPopulation: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=369 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=375 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 16 weeks (n=345, 345)
|
-1.265 percentage of HbA1c
Standard Error 0.06
|
-1.321 percentage of HbA1c
Standard Error 0.06
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 20 weeks (n=338, 334)
|
-1.294 percentage of HbA1c
Standard Error 0.06
|
-1.379 percentage of HbA1c
Standard Error 0.06
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 4 weeks (n=368, 371)
|
-0.452 percentage of HbA1c
Standard Error 0.03
|
-0.481 percentage of HbA1c
Standard Error 0.03
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 8 weeks (n=359, 358)
|
-0.871 percentage of HbA1c
Standard Error 0.05
|
-0.866 percentage of HbA1c
Standard Error 0.05
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 12 weeks (n=349, 351)
|
-1.134 percentage of HbA1c
Standard Error 0.06
|
-1.143 percentage of HbA1c
Standard Error 0.06
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
Change at 24 weeks (n=331, 329)
|
-1.336 percentage of HbA1c
Standard Error 0.06
|
-1.438 percentage of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline and Endpoint [up to 24 weeks (wk)]Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).
Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=357 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=359 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- MD Pre-Meal (n=357, 357)
|
9.09 millimoles per liter (mmol/L)
Standard Error 0.15
|
9.44 millimoles per liter (mmol/L)
Standard Error 0.15
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- AM Pre-Meal (n=353, 359)
|
8.82 millimoles per liter (mmol/L)
Standard Error 0.13
|
8.86 millimoles per liter (mmol/L)
Standard Error 0.13
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- AM 2 hrs PP (n=356, 356)
|
11.68 millimoles per liter (mmol/L)
Standard Error 0.16
|
11.80 millimoles per liter (mmol/L)
Standard Error 0.16
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- MD 2 hrs PP (n=357, 353)
|
10.65 millimoles per liter (mmol/L)
Standard Error 0.15
|
10.89 millimoles per liter (mmol/L)
Standard Error 0.15
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- EV Pre-Meal (n=356, 354)
|
9.29 millimoles per liter (mmol/L)
Standard Error 0.15
|
9.59 millimoles per liter (mmol/L)
Standard Error 0.15
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- Bed Time (n=355, 354)
|
11.25 millimoles per liter (mmol/L)
Standard Error 0.16
|
11.17 millimoles per liter (mmol/L)
Standard Error 0.16
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline- 0300 hrs (n=342, 341)
|
8.83 millimoles per liter (mmol/L)
Standard Error 0.15
|
8.96 millimoles per liter (mmol/L)
Standard Error 0.15
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- AM Pre-Meal (n=353, 359)
|
5.94 millimoles per liter (mmol/L)
Standard Error 0.11
|
6.06 millimoles per liter (mmol/L)
Standard Error 0.11
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- AM 2 hrs PP (n=356, 356)
|
8.07 millimoles per liter (mmol/L)
Standard Error 0.17
|
8.40 millimoles per liter (mmol/L)
Standard Error 0.17
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- MD Pre-Meal (n=357, 357)
|
6.81 millimoles per liter (mmol/L)
Standard Error 0.15
|
7.12 millimoles per liter (mmol/L)
Standard Error 0.15
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- MD 2 hrs PP (n=357, 353)
|
8.53 millimoles per liter (mmol/L)
Standard Error 0.17
|
8.69 millimoles per liter (mmol/L)
Standard Error 0.18
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- EV Pre-Meal (n=356, 354)
|
7.29 millimoles per liter (mmol/L)
Standard Error 0.16
|
7.40 millimoles per liter (mmol/L)
Standard Error 0.16
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- Bed Time (n=355, 354)
|
8.56 millimoles per liter (mmol/L)
Standard Error 0.18
|
8.67 millimoles per liter (mmol/L)
Standard Error 0.18
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Endpoint, up to 24 wk- 0300 hrs (n=342, 341)
|
6.72 millimoles per liter (mmol/L)
Standard Error 0.15
|
6.70 millimoles per liter (mmol/L)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).
Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose \[SMBG\] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=342 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=345 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Glycemic Variability of Fasting Blood Glucose
Baseline
|
1.18 millimoles per liter (mmol/L)
Standard Error 0.05
|
1.20 millimoles per liter (mmol/L)
Standard Error 0.05
|
|
Glycemic Variability of Fasting Blood Glucose
Endpoint, up to 24 weeks
|
0.81 millimoles per liter (mmol/L)
Standard Error 0.06
|
0.79 millimoles per liter (mmol/L)
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).
Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=370 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=374 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Change From Baseline in Body Weight
Change at 16 wk (n=342, 344)
|
1.550 kilogram (kg)
Standard Error 0.22
|
1.918 kilogram (kg)
Standard Error 0.22
|
|
Change From Baseline in Body Weight
Change at 20 wk (n=340, 333)
|
1.734 kilogram (kg)
Standard Error 0.25
|
2.234 kilogram (kg)
Standard Error 0.25
|
|
Change From Baseline in Body Weight
Change at 4 wk (n=361, 364)
|
0.292 kilogram (kg)
Standard Error 0.11
|
0.526 kilogram (kg)
Standard Error 0.11
|
|
Change From Baseline in Body Weight
Change at 8 wk (n=358, 357)
|
0.999 kilogram (kg)
Standard Error 0.16
|
1.152 kilogram (kg)
Standard Error 0.16
|
|
Change From Baseline in Body Weight
Change at 12 wk (n=350, 352)
|
1.271 kilogram (kg)
Standard Error 0.19
|
1.440 kilogram (kg)
Standard Error 0.19
|
|
Change From Baseline in Body Weight
Change at 24 wk (n=335, 329)
|
1.914 kilogram (kg)
Standard Error 0.27
|
2.175 kilogram (kg)
Standard Error 0.27
|
|
Change From Baseline in Body Weight
Change at Endpoint, up to 24 wk (n=370, 374)
|
1.776 kilogram (kg)
Standard Error 0.25
|
2.020 kilogram (kg)
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).
ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=368 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=371 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Adult Low Blood Sugar Survey (ALBSS)
Behavior Score- 12 wk (n=350, 349)
|
8.95 units on a scale
Standard Error 0.62
|
9.36 units on a scale
Standard Error 0.62
|
|
Adult Low Blood Sugar Survey (ALBSS)
Worry Score- 4 wk (n=352, 354)
|
7.74 units on a scale
Standard Error 0.91
|
8.82 units on a scale
Standard Error 0.92
|
|
Adult Low Blood Sugar Survey (ALBSS)
ALBSS Total Score- 4 wk (n=352, 354)
|
16.15 units on a scale
Standard Error 1.29
|
17.45 units on a scale
Standard Error 1.29
|
|
Adult Low Blood Sugar Survey (ALBSS)
ALBSS Total Score- 12 wk (n=349, 348)
|
17.32 units on a scale
Standard Error 1.32
|
17.85 units on a scale
Standard Error 1.32
|
|
Adult Low Blood Sugar Survey (ALBSS)
Behavior Score- 4 wk (n=351, 354)
|
8.41 units on a scale
Standard Error 0.63
|
8.64 units on a scale
Standard Error 0.64
|
|
Adult Low Blood Sugar Survey (ALBSS)
Behavior Score- Endpoint up to 24 wk (n=368, 371)
|
7.90 units on a scale
Standard Error 0.60
|
8.36 units on a scale
Standard Error 0.60
|
|
Adult Low Blood Sugar Survey (ALBSS)
Worry Score- 12 wk (n=349, 348)
|
8.35 units on a scale
Standard Error 0.91
|
8.51 units on a scale
Standard Error 0.91
|
|
Adult Low Blood Sugar Survey (ALBSS)
Worry Score- Endpoint up to 24 wk (n=368, 371)
|
8.61 units on a scale
Standard Error 0.89
|
8.57 units on a scale
Standard Error 0.90
|
|
Adult Low Blood Sugar Survey (ALBSS)
ALBSS Total Score-Endpoint up to 24 wk (n=368,371)
|
16.53 units on a scale
Standard Error 1.32
|
16.92 units on a scale
Standard Error 1.33
|
SECONDARY outcome
Timeframe: 4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=368 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=372 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IR- 4 wk (n=352, 354)
|
86.10 units on a scale
Standard Error 1.24
|
86.12 units on a scale
Standard Error 1.25
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
HC- 12 wk (n=350, 348)
|
77.15 units on a scale
Standard Error 1.49
|
77.73 units on a scale
Standard Error 1.49
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ Overall Total- EP, up to 24 wk (n=368, 372)
|
78.54 units on a scale
Standard Error 1.21
|
79.06 units on a scale
Standard Error 1.22
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IR- 12 wk (n=350, 348)
|
83.44 units on a scale
Standard Error 1.25
|
84.54 units on a scale
Standard Error 1.25
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IR- EP, up to 24 wk (n=368, 371)
|
85.62 units on a scale
Standard Error 1.31
|
85.21 units on a scale
Standard Error 1.32
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
LF- 4 wk (n=352, 354)
|
79.65 units on a scale
Standard Error 1.55
|
79.87 units on a scale
Standard Error 1.55
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
LF-12 wk (n=350, 350)
|
76.69 units on a scale
Standard Error 1.52
|
78.16 units on a scale
Standard Error 1.52
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
LF- EP, up to 24 wk (n=368, 372)
|
78.00 units on a scale
Standard Error 1.51
|
78.32 units on a scale
Standard Error 1.52
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
HC- 4 wk (n=352, 354)
|
79.36 units on a scale
Standard Error 1.46
|
80.33 units on a scale
Standard Error 1.46
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
HC- EP, up to 24 wk (n=368, 372)
|
77.51 units on a scale
Standard Error 1.54
|
79.08 units on a scale
Standard Error 1.55
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
GC- 4 wk (n=352, 354)
|
75.67 units on a scale
Standard Error 1.62
|
75.47 units on a scale
Standard Error 1.63
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
GC- 12 wk (n=350, 347)
|
78.95 units on a scale
Standard Error 1.53
|
81.38 units on a scale
Standard Error 1.53
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
GC- EP, up to 24 wk (n=368, 372)
|
80.74 units on a scale
Standard Error 1.53
|
80.26 units on a scale
Standard Error 1.54
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IDD- 4 wk (n=352, 353)
|
70.56 units on a scale
Standard Error 1.56
|
73.22 units on a scale
Standard Error 1.56
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IDD- 12 wk (n=348, 349)
|
70.97 units on a scale
Standard Error 1.70
|
72.21 units on a scale
Standard Error 1.69
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
IDD- EP, up to 24 wk (n=368, 372)
|
72.85 units on a scale
Standard Error 1.63
|
73.87 units on a scale
Standard Error 1.64
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ Overall Total- 4 wk (n=352, 354)
|
78.02 units on a scale
Standard Error 1.12
|
78.98 units on a scale
Standard Error 1.12
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ Overall Total- 12 wk (n=349, 348)
|
77.06 units on a scale
Standard Error 1.21
|
78.30 units on a scale
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).
Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=370 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=372 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Insulin Dose Per Body Weight (U/kg) Per Day
|
0.500 units per kilogram per day (U/kg/day)
Standard Error 0.03
|
0.479 units per kilogram per day (U/kg/day)
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).
Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.
Outcome measures
| Measure |
LY2963016 + OAMs
n=374 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=379 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Insulin Dose (Units)
|
44.465 units per day (U/day)
Standard Error 2.62
|
41.015 units per day (U/day)
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
LY2963016 + OAMs
n=369 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=375 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 4 weeks < 7% (n=368, 371)
|
16.6 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 4 week ≤ 6.5%(n=368, 371)
|
5.7 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 8 weeks < 7% (n=359, 358)
|
27.0 percentage of participants
|
29.9 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 8 weeks ≤ 6.5% (n=359, 358)
|
10.3 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 12 weeks <7% (n=349, 351)
|
39.3 percentage of participants
|
43.0 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- Endpoint, up to 24 weeks ≤ 6.5% (n=369,375)
|
26.8 percentage of participants
|
30.4 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at Baseline < 7.0 % (n=369, 375)
|
6.2 percentage of participants
|
7.2 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at Baseline ≤ 6.5% (n=369, 375)
|
3.5 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 12 weeks ≤ 6.5% (n=349, 351)
|
20.3 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 16 weeks <7% (n=345, 345)
|
46.7 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 16 weeks ≤ 6.5% (n=345, 345)
|
24.3 percentage of participants
|
28.4 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 20 weeks < 7% (n=338, 334)
|
49.4 percentage of participants
|
54.2 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 20 weeks ≤ 6.5% (n=338, 334)
|
26.6 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 24 weeks < 7% (n=331, 329)
|
50.8 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- at 24 weeks ≤ 6.5% (n=331, 329)
|
27.5 percentage of participants
|
32.5 percentage of participants
|
|
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
HbA1c- Endpoint, up to 24 weeks <7% (n=369, 375)
|
48.8 percentage of participants
|
52.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Endpoint (up to 24 weeks)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Outcome measures
| Measure |
LY2963016 + OAMs
n=373 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=376 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Incidence of Hypoglycemic Events
Total Events with BG ≤70 mg/dL
|
3564 hypoglycemic events in 24 weeks
|
3845 hypoglycemic events in 24 weeks
|
|
Incidence of Hypoglycemic Events
Severe Events
|
7 hypoglycemic events in 24 weeks
|
2 hypoglycemic events in 24 weeks
|
|
Incidence of Hypoglycemic Events
Nocturnal Events with BG ≤70 mg/dL
|
1248 hypoglycemic events in 24 weeks
|
1386 hypoglycemic events in 24 weeks
|
SECONDARY outcome
Timeframe: Baseline, Endpoint (up to 24 weeks)Population: All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.
The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.
Outcome measures
| Measure |
LY2963016 + OAMs
n=373 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=376 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Rate Per 30 Days of Hypoglycemic Events
Total Hypoglycemia with BG ≤70 mg/dL
|
1.75 hypoglycemic events per 30 days
Standard Deviation 2.00
|
1.83 hypoglycemic events per 30 days
Standard Deviation 2.32
|
|
Rate Per 30 Days of Hypoglycemic Events
Severe Hypoglycemia
|
0.00 hypoglycemic events per 30 days
Standard Deviation 0.05
|
0.00 hypoglycemic events per 30 days
Standard Deviation 0.01
|
|
Rate Per 30 Days of Hypoglycemic Events
Nocturnal Hypoglycemia with BG ≤70 mg/dL
|
0.61 hypoglycemic events per 30 days
Standard Deviation 0.96
|
0.66 hypoglycemic events per 30 days
Standard Deviation 1.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).
Outcome measures
| Measure |
LY2963016 + OAMs
n=365 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=365 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Detectable Insulin Antibody Levels
24 weeks (n=337, 328)
|
8.6 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Detectable Insulin Antibody Levels
Baseline (n=365, 365)
|
5.5 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Detectable Insulin Antibody Levels
4 weeks (n=362, 359)
|
7.2 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Detectable Insulin Antibody Levels
12 weeks (n= 351, 344)
|
7.1 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Detectable Insulin Antibody Levels
Endpoint, up to 24 weeks (n= 365, 365)
|
8.2 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Detectable Insulin Antibody Levels
Baseline to 24 weeks (Overall) (n= 365, 365)
|
15.3 percentage of participants
|
11.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).
TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.
Outcome measures
| Measure |
LY2963016 + OAMs
n=376 Participants
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=380 Participants
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Antibody Response (TEAR)
Endpoint, up to 24 weeks (n= 365, 365)
|
6.0 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Antibody Response (TEAR)
Overall (n= 365, 365)
|
12.3 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Antibody Response (TEAR)
4 weeks (n= 362, 359)
|
5.0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Antibody Response (TEAR)
12 weeks (n= 351, 344)
|
5.1 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Antibody Response (TEAR)
24 weeks (n=337, 328)
|
6.2 percentage of participants
|
5.2 percentage of participants
|
Adverse Events
LY2963016 + OAMs
Serious events: 15 serious events
Other events: 188 other events
Deaths: 0 deaths
Lantus + OAMs
Serious events: 18 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2963016 + OAMs
n=376 participants at risk
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=380 participants at risk
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
1/376 • Number of events 1
|
0.79%
3/380 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Coeliac disease
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
General disorders
Chest pain
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Infections and infestations
Bronchitis
|
0.27%
1/376 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.27%
1/376 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.53%
2/376 • Number of events 7
|
0.79%
3/380 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/197
|
0.55%
1/181 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Surgical and medical procedures
Cardiac operation
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Vascular disorders
Femoral artery occlusion
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Vascular disorders
Hypertensive crisis
|
0.27%
1/376 • Number of events 1
|
0.00%
0/380
|
|
Vascular disorders
Hypotension
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/376
|
0.26%
1/380 • Number of events 1
|
Other adverse events
| Measure |
LY2963016 + OAMs
n=376 participants at risk
LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
|
Lantus + OAMs
n=380 participants at risk
Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
1/376 • Number of events 1
|
1.1%
4/380 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
1.1%
4/376 • Number of events 4
|
1.1%
4/380 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
9/376 • Number of events 10
|
3.7%
14/380 • Number of events 15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
1/376 • Number of events 1
|
1.1%
4/380 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
2.1%
8/376 • Number of events 10
|
2.1%
8/380 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
5/376 • Number of events 5
|
1.6%
6/380 • Number of events 6
|
|
General disorders
Oedema peripheral
|
1.3%
5/376 • Number of events 5
|
1.6%
6/380 • Number of events 6
|
|
Infections and infestations
Bronchitis
|
1.3%
5/376 • Number of events 5
|
1.6%
6/380 • Number of events 6
|
|
Infections and infestations
Gastroenteritis
|
0.53%
2/376 • Number of events 2
|
1.1%
4/380 • Number of events 4
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
7/376 • Number of events 7
|
1.6%
6/380 • Number of events 6
|
|
Infections and infestations
Influenza
|
1.9%
7/376 • Number of events 7
|
2.9%
11/380 • Number of events 12
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
21/376 • Number of events 23
|
5.8%
22/380 • Number of events 27
|
|
Infections and infestations
Sinusitis
|
2.1%
8/376 • Number of events 8
|
0.79%
3/380 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
19/376 • Number of events 21
|
3.9%
15/380 • Number of events 18
|
|
Infections and infestations
Urinary tract infection
|
1.9%
7/376 • Number of events 9
|
1.8%
7/380 • Number of events 7
|
|
Investigations
Weight increased
|
1.3%
5/376 • Number of events 5
|
1.8%
7/380 • Number of events 7
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
1.1%
4/376 • Number of events 6
|
0.79%
3/380 • Number of events 4
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
2.7%
10/376 • Number of events 12
|
0.79%
3/380 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
7/376 • Number of events 7
|
2.1%
8/380 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
9/376 • Number of events 10
|
2.6%
10/380 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
4/376 • Number of events 4
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.27%
1/376 • Number of events 1
|
1.1%
4/380 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
4/376 • Number of events 4
|
1.3%
5/380 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
1.6%
6/376 • Number of events 8
|
1.3%
5/380 • Number of events 7
|
|
Nervous system disorders
Headache
|
2.1%
8/376 • Number of events 8
|
1.6%
6/380 • Number of events 6
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
4/376 • Number of events 4
|
1.1%
4/380 • Number of events 5
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/376
|
1.1%
4/380 • Number of events 4
|
|
Nervous system disorders
Sinus headache
|
1.3%
5/376 • Number of events 6
|
0.53%
2/380 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.27%
1/376 • Number of events 1
|
1.1%
4/380 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/376 • Number of events 1
|
1.3%
5/380 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
8/376 • Number of events 9
|
2.1%
8/380 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
3/376 • Number of events 3
|
1.1%
4/380 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
6/376 • Number of events 6
|
1.1%
4/380 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
5/376 • Number of events 5
|
1.1%
4/380 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
4/376 • Number of events 4
|
1.1%
4/380 • Number of events 6
|
|
Vascular disorders
Hypertension
|
2.1%
8/376 • Number of events 8
|
0.79%
3/380 • Number of events 3
|
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