Trial Outcomes & Findings for A Study of LY2409021 in Patients With Type 2 Diabetes (NCT NCT01241448)
NCT ID: NCT01241448
Last Updated: 2018-04-24
Results Overview
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2018-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
66
|
66
|
|
Overall Study
Intent-to-Treat Population (ITT)
|
63
|
63
|
64
|
64
|
|
Overall Study
ITT With ≥1 Post-Baseline Measure
|
61
|
61
|
64
|
62
|
|
Overall Study
COMPLETED
|
29
|
36
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
37
|
29
|
23
|
23
|
Reasons for withdrawal
| Measure |
Placebo
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
10
|
5
|
3
|
6
|
|
Overall Study
Sponsor Decision
|
17
|
14
|
12
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
3
|
6
|
|
Overall Study
Excluded due to data integrity issues
|
3
|
2
|
2
|
2
|
Baseline Characteristics
A Study of LY2409021 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=63 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=64 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=64 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 8.23 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 8.82 • n=4 Participants
|
55.7 years
STANDARD_DEVIATION 8.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Region of Enrollment
Slovakia
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race
White
|
58 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
231 Participants
n=21 Participants
|
|
Ethnicity
Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Ethnicity
Not Reported
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Diabetes Duration
|
5.8 years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 7.23 • n=7 Participants
|
5.5 years
STANDARD_DEVIATION 4.21 • n=5 Participants
|
5.8 years
STANDARD_DEVIATION 6.13 • n=4 Participants
|
6.0 years
STANDARD_DEVIATION 5.81 • n=21 Participants
|
|
Body Mass Index (BMI)
|
32.1 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.63 • n=5 Participants
|
31.9 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.86 • n=7 Participants
|
32.3 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.91 • n=5 Participants
|
32.6 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.27 • n=4 Participants
|
32.2 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.90 • n=21 Participants
|
|
Waist Circumference
|
106.7 centimeters (cm)
STANDARD_DEVIATION 12.41 • n=5 Participants
|
107.5 centimeters (cm)
STANDARD_DEVIATION 11.16 • n=7 Participants
|
107.2 centimeters (cm)
STANDARD_DEVIATION 12.24 • n=5 Participants
|
106.8 centimeters (cm)
STANDARD_DEVIATION 12.28 • n=4 Participants
|
107.1 centimeters (cm)
STANDARD_DEVIATION 11.97 • n=21 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.1 percentage of Hemoglobin A1c (HbA1c)
STANDARD_DEVIATION 1.00 • n=5 Participants
|
8.1 percentage of Hemoglobin A1c (HbA1c)
STANDARD_DEVIATION 0.93 • n=7 Participants
|
8.1 percentage of Hemoglobin A1c (HbA1c)
STANDARD_DEVIATION 0.87 • n=5 Participants
|
8.0 percentage of Hemoglobin A1c (HbA1c)
STANDARD_DEVIATION 0.92 • n=4 Participants
|
8.0 percentage of Hemoglobin A1c (HbA1c)
STANDARD_DEVIATION 0.92 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: All participants randomly assigned to treatment with at least 1 post-baseline HbA1c measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the participants were randomly assigned.
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=61 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=63 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=60 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
|
-0.15 percentage of Hemoglobin A1c (HbA1c)
Interval -0.37 to 0.06
|
-0.45 percentage of Hemoglobin A1c (HbA1c)
Interval -0.65 to -0.25
|
-0.78 percentage of Hemoglobin A1c (HbA1c)
Interval -0.97 to -0.58
|
-0.92 percentage of Hemoglobin A1c (HbA1c)
Interval -1.12 to -0.73
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All participants randomly assigned to treatment with at least 1 post-baseline laboratory FBG measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomly assigned.
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=59 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=62 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=60 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)
|
-0.36 millimoles per liter (mmol/L)
Interval -0.92 to 0.21
|
-0.46 millimoles per liter (mmol/L)
Interval -0.99 to 0.07
|
-1.07 millimoles per liter (mmol/L)
Interval -1.57 to -0.56
|
-1.14 millimoles per liter (mmol/L)
Interval -1.66 to -0.62
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline self-monitored glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
SMBG profiles consisted of blood glucose values collected before and 2 hours after the 3 main meals and at 0300 hours (3:00 AM). Values represent mean of values collected same time on 3 separate days within a week prior to visit. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=56 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=59 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=59 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
Pre-evening meal
|
-7.45 milligrams per deciliter (mg/dL)
Interval -18.88 to 3.98
|
-11.77 milligrams per deciliter (mg/dL)
Interval -21.87 to -1.66
|
-14.15 milligrams per deciliter (mg/dL)
Interval -23.95 to -4.36
|
-25.02 milligrams per deciliter (mg/dL)
Interval -34.82 to -15.22
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
Pre-morning meal (fasting)
|
-14.45 milligrams per deciliter (mg/dL)
Interval -22.26 to -6.63
|
-15.76 milligrams per deciliter (mg/dL)
Interval -22.78 to -8.74
|
-29.65 milligrams per deciliter (mg/dL)
Interval -36.56 to -22.73
|
-32.55 milligrams per deciliter (mg/dL)
Interval -39.46 to -25.64
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
2 hours after morning meal
|
-28.75 milligrams per deciliter (mg/dL)
Interval -39.55 to -17.95
|
-23.01 milligrams per deciliter (mg/dL)
Interval -32.66 to -13.35
|
-48.12 milligrams per deciliter (mg/dL)
Interval -57.42 to -38.83
|
-45.76 milligrams per deciliter (mg/dL)
Interval -55.05 to -36.47
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
Pre-mid-day meal
|
-17.83 milligrams per deciliter (mg/dL)
Interval -27.33 to -8.33
|
-16.13 milligrams per deciliter (mg/dL)
Interval -24.66 to -7.61
|
-27.35 milligrams per deciliter (mg/dL)
Interval -35.49 to -19.2
|
-25.45 milligrams per deciliter (mg/dL)
Interval -33.66 to -17.24
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
2 hours after mid-day meal
|
-23.75 milligrams per deciliter (mg/dL)
Interval -34.61 to -12.89
|
-21.17 milligrams per deciliter (mg/dL)
Interval -30.75 to -11.58
|
-31.42 milligrams per deciliter (mg/dL)
Interval -40.7 to -22.14
|
-39.60 milligrams per deciliter (mg/dL)
Interval -49.01 to -30.19
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
2 hours after evening meal
|
-19.48 milligrams per deciliter (mg/dL)
Interval -30.67 to -8.3
|
-21.74 milligrams per deciliter (mg/dL)
Interval -31.67 to -11.81
|
-33.93 milligrams per deciliter (mg/dL)
Interval -43.42 to -24.45
|
-32.01 milligrams per deciliter (mg/dL)
Interval -41.53 to -22.49
|
|
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
0300 hours (3:00 AM)
|
-5.13 milligrams per deciliter (mg/dL)
Interval -14.77 to 4.5
|
-9.52 milligrams per deciliter (mg/dL)
Interval -18.59 to -0.45
|
-23.33 milligrams per deciliter (mg/dL)
Interval -31.74 to -14.91
|
-25.67 milligrams per deciliter (mg/dL)
Interval -34.44 to -16.89
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline plasma glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=59 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=62 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=60 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Plasma Glucose
|
-0.36 millimoles per liter (mmol/L)
Interval -0.92 to 0.21
|
-0.46 millimoles per liter (mmol/L)
Interval -0.99 to 0.07
|
-1.07 millimoles per liter (mmol/L)
Interval -1.57 to -0.56
|
-1.14 millimoles per liter (mmol/L)
Interval -1.66 to -0.62
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline fasting insulin measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=58 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=60 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=59 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Fasting Insulin
|
10.62 picomoles per liter (pmol/L)
Interval -3.87 to 25.11
|
2.61 picomoles per liter (pmol/L)
Interval -9.77 to 14.98
|
14.95 picomoles per liter (pmol/L)
Interval 3.54 to 26.36
|
9.65 picomoles per liter (pmol/L)
Interval -2.56 to 21.87
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline GLP-1 active and total measurements (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. Total GLP-1 is the active GLP-1 and the Dipeptidyl Peptidase IV cleaved GLP-1 form. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=58 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=62 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=59 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total
Active GLP-1
|
-0.30 picomoles per liter (pmol/L)
Interval -0.88 to 0.28
|
0.13 picomoles per liter (pmol/L)
Interval -0.4 to 0.66
|
0.38 picomoles per liter (pmol/L)
Interval -0.11 to 0.87
|
0.31 picomoles per liter (pmol/L)
Interval -0.2 to 0.82
|
|
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total
Total GLP-1
|
-0.12 picomoles per liter (pmol/L)
Interval -1.5 to 1.27
|
1.84 picomoles per liter (pmol/L)
Interval 0.6 to 3.08
|
4.63 picomoles per liter (pmol/L)
Interval 3.48 to 5.79
|
8.23 picomoles per liter (pmol/L)
Interval 7.04 to 9.42
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline fasting lipid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Fasting Lipid Profile included: Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=59 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=62 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=59 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
Triglycerides
|
-0.11 millimoles per liter (mmol/L)
Interval -0.37 to 0.16
|
0.07 millimoles per liter (mmol/L)
Interval -0.18 to 0.31
|
0.06 millimoles per liter (mmol/L)
Interval -0.16 to 0.29
|
0.08 millimoles per liter (mmol/L)
Interval -0.14 to 0.31
|
|
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
HDL-C
|
0.03 millimoles per liter (mmol/L)
Interval -0.03 to 0.08
|
0.02 millimoles per liter (mmol/L)
Interval -0.04 to 0.07
|
0.05 millimoles per liter (mmol/L)
Interval 0.0 to 0.1
|
0.04 millimoles per liter (mmol/L)
Interval -0.01 to 0.09
|
|
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
LDL-C
|
0.20 millimoles per liter (mmol/L)
Interval -0.01 to 0.41
|
0.05 millimoles per liter (mmol/L)
Interval -0.15 to 0.24
|
0.02 millimoles per liter (mmol/L)
Interval -0.16 to 0.2
|
0.10 millimoles per liter (mmol/L)
Interval -0.08 to 0.28
|
|
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
Total Cholesterol
|
0.15 millimoles per liter (mmol/L)
Interval -0.08 to 0.39
|
0.10 millimoles per liter (mmol/L)
Interval -0.11 to 0.31
|
0.10 millimoles per liter (mmol/L)
Interval -0.1 to 0.3
|
0.19 millimoles per liter (mmol/L)
Interval -0.01 to 0.39
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline lipoprotein subfractions measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized, last observation carried forward (LOCF) principle was applied.
Subfraction included: Very Low Density Lipoprotein (VLDL) Total. Least squares mean use an analysis of covariance model. The model included baseline lipoprotein subfractions, metformin use and treatment.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=59 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=61 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=55 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)
|
1.90 nanomoles per liter (nmol/L)
Standard Error 4.296
|
6.48 nanomoles per liter (nmol/L)
Standard Error 4.048
|
0.07 nanomoles per liter (nmol/L)
Standard Error 4.099
|
2.04 nanomoles per liter (nmol/L)
Standard Error 4.328
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline free fatty acid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Least squares mean use an analysis of covariance model. The model included baseline free fatty acid, metformin use and treatment.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=56 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=60 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=56 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Free Fatty Acids
|
-0.04 picomoles per liter (pmol/L)
Standard Error 0.043
|
-0.02 picomoles per liter (pmol/L)
Standard Error 0.040
|
-0.15 picomoles per liter (pmol/L)
Standard Error 0.037
|
-0.07 picomoles per liter (pmol/L)
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline HOMA-IR measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
HOMA-IR is a computer model (based on HOMA2) which uses fasting plasma insulin and glucose concentrations to estimate insulin resistance (HOMA-IR) as a proportion reference population (normal young adults). The normal reference population with normal function was indexed to 1.0. Higher values indicate increased insulin resistance. Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=57 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=54 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=55 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
0.19 proportion of normal reference populatio
Interval -0.1 to 0.49
|
0.02 proportion of normal reference populatio
Interval -0.24 to 0.27
|
0.26 proportion of normal reference populatio
Interval 0.02 to 0.5
|
0.19 proportion of normal reference populatio
Interval -0.07 to 0.44
|
SECONDARY outcome
Timeframe: Baseline, 24 weekPopulation: All randomized patients with at least 1 post-baseline HOMA-B measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
HOMA-B is a computer model (based on HOMA-2) that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Higher values indicate greater beta cell function. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=57 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=54 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=55 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B
|
4.88 percent of normal reference population
Interval -3.27 to 13.03
|
7.90 percent of normal reference population
Interval 0.71 to 15.09
|
17.69 percent of normal reference population
Interval 10.94 to 24.43
|
16.39 percent of normal reference population
Interval 9.19 to 23.59
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized patients with at least 1 post-baseline weight measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Least squares means were adjusted for baseline weight, metformin use, visit, treatment and visit by treatment interaction.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=61 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=64 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=61 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Weight
|
-1.07 kilograms (kg)
Interval -2.2 to 0.05
|
-0.33 kilograms (kg)
Interval -1.39 to 0.73
|
0.55 kilograms (kg)
Interval -0.46 to 1.55
|
0.07 kilograms (kg)
Interval -0.95 to 1.1
|
SECONDARY outcome
Timeframe: Baseline up to 26 weeksPopulation: All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021
|
0.486 liters per hour (L/hr)
Geometric Coefficient of Variation 31.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 26 weeksPopulation: All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.
Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
|
33.4 liters (L)
Geometric Coefficient of Variation 23.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: All randomized participants who received at least 1 dose of study drug (excluding participant data from the excluded site).
A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) \[3.9 millimoles per liter (mmol/L)\].
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=63 Participants
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=64 Participants
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=64 Participants
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
The Percentage of Participants Experiencing a Hypoglycemic Episode
|
3.2 percentage of participants
|
6.3 percentage of participants
|
9.4 percentage of participants
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: Outcome measure was not analyzed due to the limited number of hypoglycemic events observed; therefore zero participants were analyzed.
A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) \[3.9 millimoles per liter (mmol/L)\]. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Outcome measure was not analyzed due to the limited number of hypoglycemic events observed.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
2.5 mg LY2409021
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
10 mg LY2409021
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
20 mg LY2409021
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=65 participants at risk
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=66 participants at risk
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=66 participants at risk
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Pyelonephritis acute
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
Other adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
2.5 mg LY2409021
n=65 participants at risk
2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
10 mg LY2409021
n=66 participants at risk
10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
20 mg LY2409021
n=66 participants at risk
20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Hordeolum
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Influenza
|
0.00%
0/66
|
4.6%
3/65 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/66
|
1.5%
1/65 • Number of events 2
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
2/66 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
6.1%
4/66 • Number of events 4
|
4.5%
3/66 • Number of events 3
|
|
Infections and infestations
Onychomycosis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Otitis externa
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Otitis media
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/66 • Number of events 1
|
6.2%
4/65 • Number of events 4
|
10.6%
7/66 • Number of events 11
|
6.1%
4/66 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/66
|
3.1%
2/65 • Number of events 2
|
10.6%
7/66 • Number of events 9
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/66
|
0.00%
0/65
|
3.0%
2/66 • Number of events 3
|
0.00%
0/66
|
|
Investigations
Blood glucose increased
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Blood potassium decreased
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/66
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
Investigations
Colonoscopy
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Free fatty acids increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
4.5%
3/66 • Number of events 6
|
4.5%
3/66 • Number of events 3
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Intermediate density lipoprotein increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Lipase increased
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Investigations
Occult blood positive
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Weight decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Investigations
Weight increased
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/66
|
1.5%
1/65 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 2
|
0.00%
0/66
|
0.00%
0/66
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Congenital, familial and genetic disorders
Type ii hyperlipidaemia
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Congenital, familial and genetic disorders
Type v hyperlipidaemia
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 2
|
0.00%
0/66
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/66 • Number of events 2
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 2
|
0.00%
0/66
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Eye disorders
Glaucoma
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/66
|
1.5%
1/65 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Constipation
|
3.0%
2/66 • Number of events 2
|
4.6%
3/65 • Number of events 5
|
0.00%
0/66
|
3.0%
2/66 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
2/66 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
6.1%
4/66 • Number of events 4
|
3.0%
2/66 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66
|
6.2%
4/65 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/66
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Asthenia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Chest pain
|
1.5%
1/66 • Number of events 1
|
3.1%
2/65 • Number of events 3
|
0.00%
0/66
|
0.00%
0/66
|
|
General disorders
Fatigue
|
0.00%
0/66
|
3.1%
2/65 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
General disorders
Thirst
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Immune system disorders
Food allergy
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Acarodermatitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/66
|
1.5%
1/65 • Number of events 2
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Body tinea
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/66
|
6.2%
4/65 • Number of events 4
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
2/66 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
3.0%
2/66 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/66
|
1.5%
1/65 • Number of events 4
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/66
|
3.1%
2/65 • Number of events 3
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Carotid arteriosclerosis
|
1.5%
1/66 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Cluster headache
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Dizziness
|
0.00%
0/66
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Headache
|
4.5%
3/66 • Number of events 3
|
4.6%
3/65 • Number of events 4
|
6.1%
4/66 • Number of events 4
|
6.1%
4/66 • Number of events 5
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Migraine
|
1.5%
1/66 • Number of events 3
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Nervous system disorders
Sinus headache
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Psychiatric disorders
Depression
|
1.5%
1/66 • Number of events 1
|
3.1%
2/65 • Number of events 4
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/66
|
4.6%
3/65 • Number of events 3
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
4.5%
3/66 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/66
|
1.5%
1/65 • Number of events 2
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/66
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
|
Surgical and medical procedures
Plastic surgery to the face
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.0%
2/66 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Vascular disorders
Phlebitis
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
1.5%
1/66 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/66
|
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