Trial Outcomes & Findings for Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes (NCT NCT00791479)
NCT ID: NCT00791479
Last Updated: 2014-12-10
Results Overview
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2014-12-10
Participant Flow
Participant milestones
| Measure |
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
34
|
29
|
3
|
32
|
|
Overall Study
Received at Least One Dose of Study Drug
|
35
|
34
|
34
|
29
|
3
|
32
|
|
Overall Study
COMPLETED
|
33
|
31
|
34
|
25
|
0
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Dose Discontinued per Sponsor Decision
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
3.0 Milligrams (mg) LY2189265
n=3 Participants
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.33 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
56.91 years
STANDARD_DEVIATION 9.06 • n=7 Participants
|
57.16 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
57.45 years
STANDARD_DEVIATION 7.88 • n=4 Participants
|
60.82 years
STANDARD_DEVIATION 7.15 • n=21 Participants
|
55.03 years
STANDARD_DEVIATION 9.33 • n=8 Participants
|
56.64 years
STANDARD_DEVIATION 8.78 • n=8 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
92 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
75 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=8 Participants
|
23 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
26 participants
n=5 Participants
|
24 participants
n=4 Participants
|
2 participants
n=21 Participants
|
25 participants
n=8 Participants
|
134 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
11 participants
n=4 Participants
|
3 participants
n=21 Participants
|
17 participants
n=8 Participants
|
75 participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=8 Participants
|
23 participants
n=8 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
5 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
16 participants
n=8 Participants
|
|
Region of Enrollment
Croatia
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
14 participants
n=8 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
5 participants
n=8 Participants
|
|
Region of Enrollment
India
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=8 Participants
|
21 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
32.92 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.75 • n=5 Participants
|
32.26 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.39 • n=7 Participants
|
32.22 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.50 • n=5 Participants
|
31.04 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.29 • n=4 Participants
|
35.38 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 3.96 • n=21 Participants
|
32.07 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.23 • n=8 Participants
|
32.20 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.83 • n=8 Participants
|
|
Duration of Diabetes
|
3.90 years
STANDARD_DEVIATION 3.19 • n=5 Participants
|
3.72 years
STANDARD_DEVIATION 3.80 • n=7 Participants
|
3.28 years
STANDARD_DEVIATION 2.54 • n=5 Participants
|
4.62 years
STANDARD_DEVIATION 4.08 • n=4 Participants
|
5.00 years
STANDARD_DEVIATION 3.04 • n=21 Participants
|
3.91 years
STANDARD_DEVIATION 4.74 • n=8 Participants
|
3.88 years
STANDARD_DEVIATION 3.68 • n=8 Participants
|
|
Body Weight
|
87.08 kilogram (kg)
STANDARD_DEVIATION 17.28 • n=5 Participants
|
90.20 kilogram (kg)
STANDARD_DEVIATION 21.34 • n=7 Participants
|
86.89 kilogram (kg)
STANDARD_DEVIATION 16.95 • n=5 Participants
|
85.81 kilogram (kg)
STANDARD_DEVIATION 18.63 • n=4 Participants
|
100.90 kilogram (kg)
STANDARD_DEVIATION 25.51 • n=21 Participants
|
90.87 kilogram (kg)
STANDARD_DEVIATION 18.94 • n=8 Participants
|
88.43 kilogram (kg)
STANDARD_DEVIATION 18.68 • n=8 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
7.13 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.55 • n=5 Participants
|
7.18 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.60 • n=7 Participants
|
7.28 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.66 • n=5 Participants
|
7.25 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.43 • n=4 Participants
|
7.63 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.15 • n=21 Participants
|
7.36 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.63 • n=8 Participants
|
7.24 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.58 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=30 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=32 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=21 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=28 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
|
-0.37 percentage of glycosylated hemoglobin
Standard Error 0.11
|
-0.89 percentage of glycosylated hemoglobin
Standard Error 0.12
|
-1.03 percentage of glycosylated hemoglobin
Standard Error 0.11
|
-1.04 percentage of glycosylated hemoglobin
Standard Error 0.13
|
0.01 percentage of glycosylated hemoglobin
Standard Error 0.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=26 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=29 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Week 4 (n=35, n=34, n=34, n=25, n=29)
|
-0.28 percentage of glycosylated hemoglobin
Standard Error 0.09
|
-0.51 percentage of glycosylated hemoglobin
Standard Error 0.09
|
-0.46 percentage of glycosylated hemoglobin
Standard Error 0.08
|
-0.53 percentage of glycosylated hemoglobin
Standard Error 0.10
|
-0.01 percentage of glycosylated hemoglobin
Standard Error 0.10
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Week 8 (n=35, n=30, n=33, n=24, n=28)
|
-0.33 percentage of glycosylated hemoglobin
Standard Error 0.10
|
-0.74 percentage of glycosylated hemoglobin
Standard Error 0.10
|
-0.78 percentage of glycosylated hemoglobin
Standard Error 0.10
|
-0.90 percentage of glycosylated hemoglobin
Standard Error 0.12
|
-0.00 percentage of glycosylated hemoglobin
Standard Error 0.11
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=28 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=31 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
|
-11.59 milligrams per deciliter (mg/dL)
Standard Error 4.09
|
-30.31 milligrams per deciliter (mg/dL)
Standard Error 4.26
|
-33.73 milligrams per deciliter (mg/dL)
Standard Error 4.18
|
-37.49 milligrams per deciliter (mg/dL)
Standard Error 4.78
|
-3.78 milligrams per deciliter (mg/dL)
Standard Error 4.44
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)
|
47.1 percentage of participants
|
73.3 percentage of participants
|
75.0 percentage of participants
|
71.4 percentage of participants
|
21.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)
|
14.7 percentage of participants
|
53.3 percentage of participants
|
50.0 percentage of participants
|
52.4 percentage of participants
|
7.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.
Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=32 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=33 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=28 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=31 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
|
-15.77 milligrams per deciliter (mg/dL)
Standard Error 4.74
|
-32.21 milligrams per deciliter (mg/dL)
Standard Error 4.88
|
-42.46 milligrams per deciliter (mg/dL)
Standard Error 4.68
|
-44.79 milligrams per deciliter (mg/dL)
Standard Error 5.46
|
-6.12 milligrams per deciliter (mg/dL)
Standard Error 5.05
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.
Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=28 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=26 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=31 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Beta-cell Function (HOMA2-%B)
|
13.18 percentage of HOMA2-%B
Standard Error 6.76
|
31.66 percentage of HOMA2-%B
Standard Error 7.04
|
39.04 percentage of HOMA2-%B
Standard Error 7.64
|
29.29 percentage of HOMA2-%B
Standard Error 8.11
|
-2.06 percentage of HOMA2-%B
Standard Error 7.44
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.
Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=27 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=33 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=24 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=22 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
|
-2.41 percentage of HOMA2-%S
Standard Error 6.62
|
6.10 percentage of HOMA2-%S
Standard Error 6.92
|
-4.80 percentage of HOMA2-%S
Standard Error 7.44
|
12.98 percentage of HOMA2-%S
Standard Error 7.95
|
0.58 percentage of HOMA2-%S
Standard Error 7.34
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=32 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=25 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=29 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
Fridericia-corrected QT (QTcF) Interval
|
1.34 millisecond (msec)
Standard Error 2.09
|
-1.18 millisecond (msec)
Standard Error 2.11
|
4.56 millisecond (msec)
Standard Error 2.01
|
-0.63 millisecond (msec)
Standard Error 2.33
|
0.70 millisecond (msec)
Standard Error 2.19
|
—
|
|
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
PR Interval
|
3.22 millisecond (msec)
Standard Error 2.20
|
4.57 millisecond (msec)
Standard Error 2.23
|
-0.55 millisecond (msec)
Standard Error 2.15
|
2.83 millisecond (msec)
Standard Error 2.46
|
-0.89 millisecond (msec)
Standard Error 2.33
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have heart rate change from baseline data available.
Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=32 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=25 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=29 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
|
1.38 beats per minute (bpm)
Standard Error 1.48
|
1.16 beats per minute (bpm)
Standard Error 1.51
|
1.88 beats per minute (bpm)
Standard Error 1.44
|
4.18 beats per minute (bpm)
Standard Error 1.67
|
0.67 beats per minute (bpm)
Standard Error 1.58
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have pulse rate change from baseline data available.
Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=25 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=30 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pulse Rate
|
0.19 beats per minute (bpm)
Standard Error 1.44
|
0.25 beats per minute (bpm)
Standard Error 1.49
|
1.02 beats per minute (bpm)
Standard Error 1.43
|
1.34 beats per minute (bpm)
Standard Error 1.65
|
1.29 beats per minute (bpm)
Standard Error 1.54
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have blood pressure change from baseline data available.
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=25 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=30 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure (BP)
Sitting Systolic Blood Pressure
|
-2.21 millimeters of mercury (mmHg)
Standard Error 2.04
|
0.51 millimeters of mercury (mmHg)
Standard Error 2.12
|
-2.57 millimeters of mercury (mmHg)
Standard Error 2.02
|
1.88 millimeters of mercury (mmHg)
Standard Error 2.33
|
-0.68 millimeters of mercury (mmHg)
Standard Error 2.18
|
—
|
|
Change From Baseline in Blood Pressure (BP)
Sitting Diastolic Blood Pressure
|
-0.24 millimeters of mercury (mmHg)
Standard Error 1.21
|
0.59 millimeters of mercury (mmHg)
Standard Error 1.26
|
0.42 millimeters of mercury (mmHg)
Standard Error 1.20
|
1.56 millimeters of mercury (mmHg)
Standard Error 1.39
|
1.07 millimeters of mercury (mmHg)
Standard Error 1.30
|
—
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Self-reported Hypoglycemic Events
Documented Symptomatic
|
0 participants
|
2 participants
|
2 participants
|
3 participants
|
0 participants
|
—
|
|
Number of Participants With Self-reported Hypoglycemic Events
Asymptomatic
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Self-reported Hypoglycemic Events
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Self-reported Hypoglycemic Events
Nocturnal
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Rate of Self-reported Hypoglycemic Events
Nocturnal Hypoglycemic Rate
|
0.20 Events per participant per year
Standard Error 0.62
|
0.16 Events per participant per year
Standard Error 0.64
|
1.21 Events per participant per year
Standard Error 0.62
|
0.21 Events per participant per year
Standard Error 0.71
|
-0.08 Events per participant per year
Standard Error 0.67
|
—
|
|
Rate of Self-reported Hypoglycemic Events
Documented Symptomatic Hypoglycemic Rate
|
-0.08 Events per participant per year
Standard Error 0.72
|
0.25 Events per participant per year
Standard Error 0.73
|
1.68 Events per participant per year
Standard Error 0.73
|
0.61 Events per participant per year
Standard Error 0.79
|
-0.09 Events per participant per year
Standard Error 0.75
|
—
|
|
Rate of Self-reported Hypoglycemic Events
Asymptomatic Hypoglycemic Rate
|
0.19 Events per participant per year
Standard Error 0.10
|
-0.01 Events per participant per year
Standard Error 0.10
|
-0.01 Events per participant per year
Standard Error 0.10
|
0.02 Events per participant per year
Standard Error 0.11
|
0.01 Events per participant per year
Standard Error 0.11
|
—
|
|
Rate of Self-reported Hypoglycemic Events
Severe Hypoglycemic Rate
|
0 Events per participant per year
Standard Error 0
|
0 Events per participant per year
Standard Error 0
|
0 Events per participant per year
Standard Error 0
|
0 Events per participant per year
Standard Error 0
|
0 Events per participant per year
Standard Error 0
|
—
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Participants who received at least one dose of study drug.
A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=3 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events
|
21 participants
|
17 participants
|
20 participants
|
18 participants
|
1 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received at least one dose of study drug and have body weight change from baseline data available.
Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=34 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=25 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=30 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-0.19 kilogram (kg)
Standard Error 0.42
|
-0.34 kilogram (kg)
Standard Error 0.43
|
-1.11 kilogram (kg)
Standard Error 0.42
|
-1.49 kilogram (kg)
Standard Error 0.48
|
-1.38 kilogram (kg)
Standard Error 0.45
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 16 weeksPopulation: Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.
LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=32 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Antibody Production and Effects to LY2189265
Week 12
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Antibody Production and Effects to LY2189265
Week 4
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Antibody Production and Effects to LY2189265
Week 16
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks, 8 weeks, 12 weeksPopulation: Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams \[mg\]) with evaluable pharmacokinetic data.
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Outcome measures
| Measure |
0.1 Milligrams (mg) LY2189265
n=27 Participants
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=31 Participants
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 Participants
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=27 Participants
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
n=2 Participants
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
|
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
|
2294 nanograms*hour/milliliter (ng*h/mL)
Standard Deviation 1503
|
6650 nanograms*hour/milliliter (ng*h/mL)
Standard Deviation 4356
|
11671 nanograms*hour/milliliter (ng*h/mL)
Standard Deviation 7645
|
16649 nanograms*hour/milliliter (ng*h/mL)
Standard Deviation 10905
|
31538 nanograms*hour/milliliter (ng*h/mL)
Standard Deviation 20657
|
—
|
Adverse Events
0.1 Milligrams (mg) LY2189265
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
0.5 Milligrams (mg) LY2189265
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
1.0 Milligrams (mg) LY2189265
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
1.5 Milligrams (mg) LY2189265
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
3.0 Milligrams (mg) LY2189265
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 participants at risk
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 participants at risk
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 participants at risk
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 participants at risk
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
3.0 Milligrams (mg) LY2189265
n=3 participants at risk
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Placebo
n=32 participants at risk
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/29
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
0.00%
0/32
|
Other adverse events
| Measure |
0.1 Milligrams (mg) LY2189265
n=35 participants at risk
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
0.5 Milligrams (mg) LY2189265
n=34 participants at risk
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.0 Milligrams (mg) LY2189265
n=34 participants at risk
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
1.5 Milligrams (mg) LY2189265
n=29 participants at risk
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
3.0 Milligrams (mg) LY2189265
n=3 participants at risk
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
Placebo
n=32 participants at risk
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
2/35 • Number of events 7
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
6.9%
2/29 • Number of events 2
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • Number of events 3
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
10.3%
3/29 • Number of events 3
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • Number of events 3
|
8.8%
3/34 • Number of events 4
|
2.9%
1/34 • Number of events 1
|
10.3%
3/29 • Number of events 3
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 4
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
13.8%
4/29 • Number of events 5
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 2
|
0.00%
0/3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Nausea
|
11.4%
4/35 • Number of events 4
|
0.00%
0/34
|
11.8%
4/34 • Number of events 4
|
6.9%
2/29 • Number of events 2
|
0.00%
0/3
|
9.4%
3/32 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
6.9%
2/29 • Number of events 3
|
0.00%
0/3
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/35
|
5.9%
2/34 • Number of events 2
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Hunger
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Injection site haematoma
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35
|
5.9%
2/34 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
10.3%
3/29 • Number of events 3
|
0.00%
0/3
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Otitis media
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
0.00%
0/29
|
0.00%
0/3
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
6.9%
2/29 • Number of events 2
|
0.00%
0/3
|
0.00%
0/32
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/24
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/16
|
0.00%
0/3
|
7.1%
1/14 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 4
|
0.00%
0/3
|
0.00%
0/32
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Lipase increased
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
6.9%
2/29 • Number of events 2
|
0.00%
0/3
|
0.00%
0/32
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/29
|
0.00%
0/3
|
0.00%
0/32
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35
|
5.9%
2/34 • Number of events 2
|
0.00%
0/34
|
3.4%
1/29 • Number of events 2
|
0.00%
0/3
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 2
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
11.8%
4/34 • Number of events 5
|
6.9%
2/29 • Number of events 2
|
0.00%
0/3
|
0.00%
0/32
|
|
Nervous system disorders
Hypoaesthesia
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
0.00%
0/32
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/3
|
0.00%
0/32
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/29
|
0.00%
0/3
|
3.1%
1/32 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60