Trial Outcomes & Findings for A Study for Participants With Type 2 Diabetes Mellitus (NCT NCT00871572)
NCT ID: NCT00871572
Last Updated: 2018-04-24
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2018-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
10 milligram (mg) LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
17
|
34
|
26
|
|
Overall Study
≥1 Post Baseline Value by Assigned Group
|
9
|
17
|
34
|
25
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
9
|
17
|
34
|
25
|
|
Overall Study
COMPLETED
|
8
|
11
|
30
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
10 milligram (mg) LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
3
|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
1
|
Baseline Characteristics
A Study for Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=17 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=34 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=26 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 4.92 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 6.41 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 8.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=31 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
|
0.11 percentage of HbA1c
Interval -0.44 to 0.65
|
-0.83 percentage of HbA1c
Interval -1.28 to -0.38
|
-0.65 percentage of HbA1c
Interval -0.93 to -0.37
|
-0.66 percentage of HbA1c
Interval -1.0 to -0.31
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline FBG measurement and analyzed according to the assigned treatment.
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=10 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=31 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=20 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline Values for Fasting Blood Glucose (FBG)
|
1.19 millimoles/liter (mmol/L)
Interval -0.93 to 3.32
|
-0.43 millimoles/liter (mmol/L)
Interval -2.3 to 1.44
|
-0.67 millimoles/liter (mmol/L)
Interval -1.76 to 0.42
|
-1.22 millimoles/liter (mmol/L)
Interval -2.55 to 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline OGTT measurement and analyzed according to the assigned treatment.
LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=10 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=29 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
|
172.89 mmol/L
Interval -117.67 to 463.46
|
48.34 mmol/L
Interval -178.2 to 274.88
|
-165.74 mmol/L
Interval -297.35 to -34.14
|
-293.94 mmol/L
Interval -458.59 to -129.29
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting triglyceride measurement and analyzed according to the assigned treatment.
LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=10 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=30 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint for Fasting Triglycerides
|
0.1 mmol/L
Standard Error 0.24
|
0.2 mmol/L
Standard Error 0.20
|
0.2 mmol/L
Standard Error 0.12
|
0 mmol/L
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline DSC-R measurement and analyzed according to the assigned treatment.
The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=17 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=34 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=36 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Cardiovascular
|
2.5 units on a scale
Standard Deviation NA
One (1) participant analyzed, therefore, the standard deviation (SD) was not calculated.
|
1.52 units on a scale
Standard Deviation 0.372
|
1.52 units on a scale
Standard Deviation 0.475
|
1.69 units on a scale
Standard Deviation 0.586
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Hyperglycemic
|
3.18 units on a scale
Standard Deviation 1.517
|
2.79 units on a scale
Standard Deviation 1.086
|
2.30 units on a scale
Standard Deviation 0.437
|
2.37 units on a scale
Standard Deviation 0.563
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Hypoglycemic
|
1.50 units on a scale
Standard Deviation 0707
|
2.42 units on a scale
Standard Deviation 1.258
|
2.50 units on a scale
Standard Deviation 0.980
|
2.00 units on a scale
Standard Deviation 1.277
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Neurological-Pain
|
2.00 units on a scale
Standard Deviation NA
One (1) participant analyzed, therefore, the SD was not calculated.
|
1.91 units on a scale
Standard Deviation 0.717
|
1.88 units on a scale
Standard Deviation 0.396
|
1.80 units on a scale
Standard Deviation 0636
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Neurological-Sensory
|
2.39 units on a scale
Standard Deviation 0.438
|
1.89 units on a scale
Standard Deviation 0.587
|
2.35 units on a scale
Standard Deviation 0.596
|
2.11 units on a scale
Standard Deviation 0.893
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Visual
|
1.00 units on a scale
Standard Deviation NA
One (1) participant analyzed, therefore, the SD was not calculated.
|
2.45 units on a scale
Standard Deviation 1.172
|
2.03 units on a scale
Standard Deviation 0.812
|
2.05 units on a scale
Standard Deviation 1.160
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Psychological-Cognitive
|
1.61 units on a scale
Standard Deviation 0.860
|
2.31 units on a scale
Standard Deviation 0.875
|
2.37 units on a scale
Standard Deviation 0.967
|
1.69 units on a scale
Standard Deviation 0.636
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Psychological-Fatigue
|
1.91 units on a scale
Standard Deviation 0.219
|
2.06 units on a scale
Standard Deviation 0.734
|
2.33 units on a scale
Standard Deviation 0.584
|
2.07 units on a scale
Standard Deviation 0.500
|
|
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Total
|
NA units on a scale
Standard Deviation NA
Total was not calculated due to too much missing subdomain data as per the protocol.
|
NA units on a scale
Standard Deviation NA
Total was not calculated due to too much missing subdomain data as per the protocol.
|
NA units on a scale
Standard Deviation NA
Total was not calculated due to too much missing subdomain data as per the protocol.
|
NA units on a scale
Standard Deviation NA
Total was not calculated due to too much missing subdomain data as per the protocol.
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline Diabetes Medicines Survey measurement and analyzed according to the assigned treatment.
The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=30 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication controlling blood sugar(BS)
|
1.75 units on a scale
Standard Deviation 0.886
|
2.00 units on a scale
Standard Deviation 0.894
|
1.77 units on a scale
Standard Deviation 0.679
|
1.53 units on a scale
Standard Deviation 0.697
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Meeting medical needs
|
1.75 units on a scale
Standard Deviation 0.886
|
2.09 units on a scale
Standard Deviation 0.831
|
1.80 units on a scale
Standard Deviation 0.805
|
1.58 units on a scale
Standard Deviation 0.769
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication working well
|
1.75 units on a scale
Standard Deviation 0.886
|
2.00 units on a scale
Standard Deviation 0.894
|
1.70 units on a scale
Standard Deviation 0.794
|
1.63 units on a scale
Standard Deviation 0.831
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication giving good results
|
1.88 units on a scale
Standard Deviation 0.835
|
2.00 units on a scale
Standard Deviation 0.894
|
1.87 units on a scale
Standard Deviation 0.776
|
1.58 units on a scale
Standard Deviation 0692
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication making me feel better
|
2.00 units on a scale
Standard Deviation 1.069
|
2.09 units on a scale
Standard Deviation 0.831
|
1.90 units on a scale
Standard Deviation 0.712
|
1.84 units on a scale
Standard Deviation 0.688
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication taking care of illness
|
2.00 units on a scale
Standard Deviation 1.069
|
2.09 units on a scale
Standard Deviation 0.831
|
1.83 units on a scale
Standard Deviation 0.834
|
1.58 units on a scale
Standard Deviation 0.692
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication therapy is failing
|
3.63 units on a scale
Standard Deviation 0.744
|
3.18 units on a scale
Standard Deviation 0.874
|
3.17 units on a scale
Standard Deviation 0.928
|
3.58 units on a scale
Standard Deviation 0769
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication giving 24-hour control
|
2.13 units on a scale
Standard Deviation 1.126
|
2.27 units on a scale
Standard Deviation 1.104
|
2.03 units on a scale
Standard Deviation 0.823
|
1.68 units on a scale
Standard Deviation 0.671
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication therapy is effective
|
1.88 units on a scale
Standard Deviation 0.835
|
2.09 units on a scale
Standard Deviation 0.944
|
1.87 units on a scale
Standard Deviation 0.730
|
1.74 units on a scale
Standard Deviation 0.733
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Medication keeping BS stable
|
2.00 units on a scale
Standard Deviation 0.926
|
2.18 units on a scale
Standard Deviation 0.982
|
1.97 units on a scale
Standard Deviation 0.718
|
1.68 units on a scale
Standard Deviation 0.671
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Constipation
|
3.88 units on a scale
Standard Deviation 0.354
|
3.18 units on a scale
Standard Deviation 1.168
|
3.83 units on a scale
Standard Deviation 0.379
|
3.63 units on a scale
Standard Deviation 0.761
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Feet or hands swelling
|
3.75 units on a scale
Standard Deviation 0.463
|
3.91 units on a scale
Standard Deviation 0.302
|
3.80 units on a scale
Standard Deviation 0.407
|
3.84 units on a scale
Standard Deviation 0.375
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Headaches
|
3.63 units on a scale
Standard Deviation 0.518
|
3.45 units on a scale
Standard Deviation 0.688
|
3.60 units on a scale
Standard Deviation 0563
|
3.79 units on a scale
Standard Deviation 0.419
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Weight gain
|
3.63 units on a scale
Standard Deviation 0.518
|
3.73 units on a scale
Standard Deviation 0.467
|
3.57 units on a scale
Standard Deviation 0.728
|
3.79 units on a scale
Standard Deviation 0.419
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Dizziness/Lightheaded
|
3.75 units on a scale
Standard Deviation 0.463
|
3.73 units on a scale
Standard Deviation 0.467
|
3.90 units on a scale
Standard Deviation 0.403
|
3.89 units on a scale
Standard Deviation 0.315
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Muscle Cramps
|
3.88 units on a scale
Standard Deviation 0.354
|
3.64 units on a scale
Standard Deviation 0.809
|
3.87 units on a scale
Standard Deviation 0.346
|
3.58 units on a scale
Standard Deviation 0.769
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Bloating
|
3.63 units on a scale
Standard Deviation 0.518
|
3.82 units on a scale
Standard Deviation 0.405
|
3.83 units on a scale
Standard Deviation 0.379
|
3.79 units on a scale
Standard Deviation 0.419
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Diarrhea
|
3.38 units on a scale
Standard Deviation 0.744
|
3.73 units on a scale
Standard Deviation 0.467
|
3.70 units on a scale
Standard Deviation 0.596
|
3.74 units on a scale
Standard Deviation 0.452
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Heartburn
|
3.75 units on a scale
Standard Deviation 0.463
|
3.73 units on a scale
Standard Deviation 0.647
|
3.72 units on a scale
Standard Deviation 0.528
|
3.79 units on a scale
Standard Deviation 0.535
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Excessive Sweating
|
3.75 units on a scale
Standard Deviation 0.463
|
3.64 units on a scale
Standard Deviation 0.809
|
3.77 units on a scale
Standard Deviation 0.568
|
3.79 units on a scale
Standard Deviation 0.535
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Itching
|
3.88 units on a scale
Standard Deviation 0.354
|
3.73 units on a scale
Standard Deviation 0.467
|
3.90 units on a scale
Standard Deviation 0.403
|
3.84 units on a scale
Standard Deviation 0.501
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Hypoglycemia
|
4.00 units on a scale
Standard Deviation 0.000
|
3.82 units on a scale
Standard Deviation 0.405
|
3.90 units on a scale
Standard Deviation 0.305
|
3.89 units on a scale
Standard Deviation 0.315
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Stomach Pain
|
3.75 units on a scale
Standard Deviation 0.707
|
3.73 units on a scale
Standard Deviation 0.647
|
3.93 units on a scale
Standard Deviation 0.254
|
3.84 units on a scale
Standard Deviation 0.375
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Upset Stomach
|
3.63 units on a scale
Standard Deviation 0.744
|
4.00 units on a scale
Standard Deviation 0.000
|
3.90 units on a scale
Standard Deviation 0.305
|
3.79 units on a scale
Standard Deviation 0.535
|
|
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Side Effect: Muscle Soreness
|
3.75 units on a scale
Standard Deviation 0.463
|
3.82 units on a scale
Standard Deviation 0.603
|
3.77 units on a scale
Standard Deviation 0.504
|
3.63 units on a scale
Standard Deviation 0.597
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline 7-Point SMBG measurement and analyzed according to the assigned treatment.
Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=28 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=18 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Pre-Morning Meal Fasting
|
13.46 milligrams/deciliter (mg/dL)
Interval -2.23 to 29.15
|
-10.09 milligrams/deciliter (mg/dL)
Interval -23.27 to 3.08
|
-21.82 milligrams/deciliter (mg/dL)
Interval -30.19 to -13.44
|
-25.86 milligrams/deciliter (mg/dL)
Interval -36.2 to -15.52
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
2 Hours After Morning Meal
|
-27.48 milligrams/deciliter (mg/dL)
Interval -49.06 to -5.9
|
-33.90 milligrams/deciliter (mg/dL)
Interval -52.13 to -15.67
|
-35.68 milligrams/deciliter (mg/dL)
Interval -46.98 to -24.38
|
-34.68 milligrams/deciliter (mg/dL)
Interval -48.61 to -20.75
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Pre Mid-Day Meal
|
16.43 milligrams/deciliter (mg/dL)
Interval -2.08 to 34.94
|
-19.39 milligrams/deciliter (mg/dL)
Interval -35.07 to -3.71
|
-16.72 milligrams/deciliter (mg/dL)
Interval -26.55 to -6.9
|
-21.44 milligrams/deciliter (mg/dL)
Interval -33.55 to -9.33
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
2 Hours After Mid-Day Meal
|
-6.86 milligrams/deciliter (mg/dL)
Interval -27.59 to 13.88
|
-35.34 milligrams/deciliter (mg/dL)
Interval -52.73 to -17.94
|
-22.51 milligrams/deciliter (mg/dL)
Interval -33.57 to -11.46
|
-29.42 milligrams/deciliter (mg/dL)
Interval -42.91 to -15.92
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Pre Evening Meal
|
28.16 milligrams/deciliter (mg/dL)
Interval 5.23 to 51.08
|
-16.62 milligrams/deciliter (mg/dL)
Interval -36.01 to 2.77
|
-26.29 milligrams/deciliter (mg/dL)
Interval -38.48 to -14.11
|
-18.03 milligrams/deciliter (mg/dL)
Interval -33.0 to -3.07
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
2 Hours After Evening Meal
|
12.02 milligrams/deciliter (mg/dL)
Interval -11.55 to 35.58
|
-27.80 milligrams/deciliter (mg/dL)
Interval -47.3 to -8.31
|
-31.78 milligrams/deciliter (mg/dL)
Interval -44.13 to -19.42
|
-27.54 milligrams/deciliter (mg/dL)
Interval -42.73 to -12.34
|
|
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Bedtime
|
17.19 milligrams/deciliter (mg/dL)
Interval -5.34 to 39.72
|
-19.69 milligrams/deciliter (mg/dL)
Interval -38.75 to -0.63
|
-29.31 milligrams/deciliter (mg/dL)
Interval -41.14 to -17.48
|
-24.88 milligrams/deciliter (mg/dL)
Interval -39.84 to -9.92
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting insulin measurement and analyzed according to the assigned treatment.
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=30 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline Values for Fasting Insulin
|
-10.91 picomole/liter (pmol/L)
Interval -56.58 to 34.76
|
14.71 picomole/liter (pmol/L)
Interval -21.17 to 50.59
|
-5.51 picomole/liter (pmol/L)
Interval -27.5 to 16.49
|
13.34 picomole/liter (pmol/L)
Interval -14.08 to 40.76
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting glucagon measurement and analyzed according to the assigned treatment.
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=31 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline Values for Fasting Glucagon
|
-2.36 pmol/L
Interval -70.57 to 65.85
|
52.71 pmol/L
Interval -1.84 to 107.25
|
87.32 pmol/L
Interval 52.35 to 122.3
|
104.90 pmol/L
Interval 61.28 to 148.52
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting GLP-1 measurement and analyzed according to the assigned treatment.
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=29 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
|
-1.43 pmol/L
Interval -3.44 to 0.58
|
0.44 pmol/L
Interval -1.24 to 2.13
|
0.61 pmol/L
Interval -0.45 to 1.66
|
0.28 pmol/L
Interval -1.0 to 1.57
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline AUC from OGTT measurement and analyzed according to the assigned treatment.
LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=10 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=28 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=17 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline for Insulin AUC From OGTT
|
2357.88 pmol/L
Interval -14350.13 to 19065.88
|
10376.38 pmol/L
Interval -2525.67 to 23278.44
|
7532.72 pmol/L
Interval -199.74 to 15265.19
|
20511.79 pmol/L
Interval 10583.81 to 30439.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: all randomized participants with at least 1 post baseline C-peptide AUC from OGTTmeasurement and analyzed according to the assigned treatment.
LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=11 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=29 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=19 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline for C-Peptide AUC From OGTT
|
20380.84 pmol/L
Interval -38421.86 to 79183.54
|
38475.16 pmol/L
Interval -4765.49 to 81715.81
|
26164.43 pmol/L
Interval -535.64 to 52864.5
|
56599.82 pmol/L
Interval 23333.38 to 89866.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting LDL measurement and analyzed according to the assigned treatment; last observation carried forward (LOCF).
Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=16 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=31 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=21 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
|
0.4 mmol/L
Standard Error 0.21
|
0.3 mmol/L
Standard Error 0.15
|
0.2 mmol/L
Standard Error 0.11
|
0.3 mmol/L
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting HDL measurement and analyzed according to the assigned treatment; LOCF.
Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=16 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=32 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=22 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
|
-0.1 mmol/L
Standard Error 0.11
|
0 mmol/L
Standard Error 0.07
|
0.1 mmol/L
Standard Error 0.05
|
0 mmol/L
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting non-HDL cholesterol measurement and analyzed according to the assigned treatment; LOCF.
Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=16 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=32 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=22 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint for Non-HDL Cholesterol
|
0.5 mmol/L
Standard Error 0.24
|
0.3 mmol/L
Standard Error 0.17
|
0.3 mmol/L
Standard Error 0.12
|
0.3 mmol/L
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants with at least 1 post baseline fasting total cholesterol measurement and analyzed according to the assigned treatment; LOCF.
Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=16 Participants
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=33 Participants
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=23 Participants
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Endpoint for Total Cholesterol
|
0.3 mmol/L
Standard Error 0.24
|
0.3 mmol/L
Standard Error 0.18
|
0.3 mmol/L
Standard Error 0.12
|
0.4 mmol/L
Standard Error 0.15
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg LY2409021
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
30 mg LY2409021
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
60 mg LY2409021
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=17 participants at risk
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=34 participants at risk
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=25 participants at risk
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/9
|
0.00%
0/17
|
0.00%
0/34
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo was administered orally once daily as 4 capsules for 12 weeks.
|
10 mg LY2409021
n=17 participants at risk
10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
|
30 mg LY2409021
n=34 participants at risk
30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
|
60 mg LY2409021
n=25 participants at risk
60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
4.0%
1/25 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9
|
0.00%
0/17
|
8.8%
3/34 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
5.9%
2/34 • Number of events 6
|
16.0%
4/25 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
14.7%
5/34 • Number of events 5
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
2.9%
1/34 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
General disorders
Fatigue
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
|
General disorders
Influenza like illness
|
0.00%
0/9
|
0.00%
0/17
|
0.00%
0/34
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Thirst
|
0.00%
0/9
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9
|
11.8%
2/17 • Number of events 2
|
0.00%
0/34
|
0.00%
0/25
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint sprain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9
|
0.00%
0/17
|
2.9%
1/34 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Blood pressure increased
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Investigations
Lipase increased
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
5.9%
2/34 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Weight increased
|
0.00%
0/9
|
0.00%
0/17
|
11.8%
4/34 • Number of events 4
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9
|
17.6%
3/17 • Number of events 4
|
5.9%
2/34 • Number of events 4
|
16.0%
4/25 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9
|
17.6%
3/17 • Number of events 3
|
0.00%
0/34
|
8.0%
2/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9
|
0.00%
0/17
|
5.9%
2/34 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9
|
17.6%
3/17 • Number of events 3
|
5.9%
2/34 • Number of events 4
|
0.00%
0/25
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
5.9%
2/34 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
14.7%
5/34 • Number of events 5
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
0.00%
0/34
|
0.00%
0/25
|
|
Vascular disorders
Hot flush
|
0.00%
0/9
|
5.9%
1/17 • Number of events 1
|
0.00%
0/34
|
0.00%
0/25
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1
|
0.00%
0/17
|
2.9%
1/34 • Number of events 1
|
0.00%
0/25
|
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