A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
99
Recruiting sites
-
Actual enrollment
1,202
Study population
Type 2 diabetes
Eligibility highlights
•BMI 25-40•HbA1c 7-9.5%
Primary endpoint
•HbA1c, change
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (66)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
4 endpointsResource Utilization
Time frame:Baseline through 52 and 104 weeks
event count, event
Posted result
| Group | Number · events | 95% CI |
|---|---|---|
| 1.5 mg LY218926552 Weeks | NA | - |
| 104 Weeks | NA | - |
| 0.75 mg LY218926552 Weeks | NA | - |
| 104 Weeks | NA | - |
| Sitagliptin52 Weeks | NA | - |
| 104 Weeks | NA | - |
Resource Utilization
Time frame:Baseline through 52 and 104 weeks
event count, descriptive
Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks
Time frame:Baseline through 104 weeks
Expanded / custom MACE composite
composite event, event
componentsCardiovascular death, All-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization
Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks
Time frame:Baseline through 104 weeks
Expanded / custom MACE composite
event count, event
componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 3.0 mg LY2189265Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| 2.0 mg LY2189265Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| 1.5 mg LY2189265Participants With Any CV Event | 6 | - |
| Participants With a Fatal CV Event | 1 | - |
| Participants With a Non-fatal CV Event | 6 | - |
| 1.0 mg LY2189265Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| 0.75 mg LY2189265Participants With Any CV Event | 4 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 4 | - |
| 0.5 mg LY2189265Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| 0.25 mg LY2189265Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| SitagliptinParticipants With Any CV Event | 5 | - |
| Participants With a Fatal CV Event | 1 | - |
| Participants With a Non-fatal CV Event | 4 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Participants With Any CV Event | 0 | - |
| Participants With a Fatal CV Event | 0 | - |
| Participants With a Non-fatal CV Event | 0 | - |
| Placebo/Sitagliptin (26 Weeks Through 104 Weeks)Participants With Any CV Event | 3 | - |
| Participants With a Fatal CV Event | 1 | - |
| Participants With a Non-fatal CV Event | 2 | - |
Weight & body composition
8 endpointsChange From Baseline in Body Weight at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · kilograms (kg) | 95% CI |
|---|---|---|
| 3.0 mg LY2189265 | -3.32 | - |
| 2.0 mg LY2189265 | -2.15 | - |
| 1.5 mg LY2189265 | -2.12 | - |
| 1.0 mg LY2189265 | -2.23 | - |
| 0.75 mg LY2189265 | -1.17 | - |
| 0.5 mg LY2189265 | -1.53 | - |
| 0.25 mg LY2189265 | -0.85 | - |
| Sitagliptin | -0.43 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks) | -0.56 | - |
Body Weight Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Least-squares mean · kilograms (kg) | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks | -3.18 | - |
| 52 Weeks | -3.03 | - |
| 104 Weeks | -2.88 | - |
| 0.75 mg LY218926526 Weeks | -2.63 | - |
| 52 Weeks | -2.60 | - |
| 104 Weeks | -2.39 | - |
| Sitagliptin26 Weeks | -1.46 | - |
| 52 Weeks | -1.53 | - |
| 104 Weeks | -1.75 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks | -1.47 | - |
| 52 Weeks | NA | - |
| 104 Weeks | NA | - |
Durability of Change From Baseline Body Weight
Time frame:Baseline, 13, 26, 52, and 104 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Least-squares mean · kilograms (kg) | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks Versus 13 Weeks (n=271, 278, 282, 138) | -0.53 | - |
| 52 Weeks Versus 26 Weeks (n=246, 255, 253) | 0.17 | - |
| 104 Weeks Versus 26 Weeks (n=197, 192, 191) | 0.42 | - |
| 0.75 mg LY218926526 Weeks Versus 13 Weeks (n=271, 278, 282, 138) | -0.57 | - |
| 52 Weeks Versus 26 Weeks (n=246, 255, 253) | 0.06 | - |
| 104 Weeks Versus 26 Weeks (n=197, 192, 191) | 0.32 | - |
| Sitagliptin26 Weeks Versus 13 Weeks (n=271, 278, 282, 138) | -0.42 | - |
| 52 Weeks Versus 26 Weeks (n=246, 255, 253) | -0.04 | - |
| 104 Weeks Versus 26 Weeks (n=197, 192, 191) | -0.39 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks Versus 13 Weeks (n=271, 278, 282, 138) | -0.37 | - |
| 52 Weeks Versus 26 Weeks (n=246, 255, 253) | NA | - |
| 104 Weeks Versus 26 Weeks (n=197, 192, 191) | NA | - |
Waist Circumference Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Least-squares mean · centimeters (cm) | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks (n=266, 273, 277, 138) | -2.89 | - |
| 52 Weeks (n=238, 250, 247) | -2.91 | - |
| 104 Weeks (n=192, 189, 188) | -2.57 | - |
| 0.75 mg LY218926526 Weeks (n=266, 273, 277, 138) | -1.78 | - |
| 52 Weeks (n=238, 250, 247) | -2.05 | - |
| 104 Weeks (n=192, 189, 188) | -1.75 | - |
| Sitagliptin26 Weeks (n=266, 273, 277, 138) | -1.45 | - |
| 52 Weeks (n=238, 250, 247) | -1.45 | - |
| 104 Weeks (n=192, 189, 188) | -1.20 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks (n=266, 273, 277, 138) | -1.20 | - |
| 52 Weeks (n=238, 250, 247) | NA | - |
| 104 Weeks (n=192, 189, 188) | NA | - |
Change From Baseline in Body Weight at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Body Weight Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Durability of Change From Baseline Body Weight
Time frame:Baseline, 13, 26, 52, and 104 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Waist Circumference Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
16 endpointsGlycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame:Baseline, 52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Least-squares mean · percentage of HbA1c | 95% CI |
|---|---|---|
| 1.5 mg LY2189265 | -1.10 | - |
| 0.75 mg LY2189265 | -0.87 | - |
| Sitagliptin | -0.39 | - |
Superiority analysis
Superiority analysis
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame:Baseline, 52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point
Time frame:Baseline up to 27.4 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Mean · percentage of HbA1c | 95% CI |
|---|---|---|
| 3.0 mg LY2189265 | -1.09 | - |
| 2.0 mg LY2189265 | -1.25 | - |
| 1.5 mg LY2189265 | -1.49 | - |
| 1.0 mg LY2189265 | -0.98 | - |
| 0.75 mg LY2189265 | -1.02 | - |
| 0.5 mg LY2189265 | -0.94 | - |
| 0.25 mg LY2189265 | -0.70 | - |
| Sitagliptin | -0.76 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks) | -0.06 | - |
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame:Baseline, 26 weeks, 104 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Least-squares mean · percentage of HbA1c | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks | -1.22 | - |
| 104 Weeks | -0.99 | - |
| 0.75 mg LY218926526 Weeks | -1.01 | - |
| 104 Weeks | -0.71 | - |
| Sitagliptin26 Weeks | -0.61 | - |
| 104 Weeks | -0.32 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks | 0.03 | - |
| 104 Weeks | NA | - |
Superiority analysis
Superiority analysis
Superiority analysis
Superiority analysis
Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame:Baseline, 13, 26, 52, and 104 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Least-squares mean · percentage of HbA1c | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks Versus 13 Weeks (n=269, 269, 276, 136) | -0.03 | - |
| 52 Weeks Versus 26 Weeks (n=245, 254, 250) | 0.14 | - |
| 104 Weeks Versus 52 Weeks (n=194, 191, 190) | 0.13 | - |
| 0.75 mg LY218926526 Weeks Versus 13 Weeks (n=269, 269, 276, 136) | 0.02 | - |
| 52 Weeks Versus 26 Weeks (n=245, 254, 250) | 0.16 | - |
| 104 Weeks Versus 52 Weeks (n=194, 191, 190) | 0.16 | - |
| Sitagliptin26 Weeks Versus 13 Weeks (n=269, 269, 276, 136) | 0.00 | - |
| 52 Weeks Versus 26 Weeks (n=245, 254, 250) | 0.24 | - |
| 104 Weeks Versus 52 Weeks (n=194, 191, 190) | 0.09 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks Versus 13 Weeks (n=269, 269, 276, 136) | -0.14 | - |
| 52 Weeks Versus 26 Weeks (n=245, 254, 250) | NA | - |
| 104 Weeks Versus 52 Weeks (n=194, 191, 190) | NA | - |
Fasting Blood Glucose Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Least-squares mean · millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks (n=265, 271, 276, 135) | -2.38 | - |
| 52 Weeks (n=239, 247, 244) | -2.38 | - |
| 104 Weeks (n=190, 187, 181) | -1.99 | - |
| 0.75 mg LY218926526 Weeks (n=265, 271, 276, 135) | -1.97 | - |
| 52 Weeks (n=239, 247, 244) | -1.63 | - |
| 104 Weeks (n=190, 187, 181) | -1.39 | - |
| Sitagliptin26 Weeks (n=265, 271, 276, 135) | -0.97 | - |
| 52 Weeks (n=239, 247, 244) | -0.90 | - |
| 104 Weeks (n=190, 187, 181) | -0.47 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks (n=265, 271, 276, 135) | -0.49 | - |
| 52 Weeks (n=239, 247, 244) | NA | - |
| 104 Weeks (n=190, 187, 181) | NA | - |
Fasting Insulin Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
change from baseline, improvement
Posted result
| Group | Least-squares mean · picomoles per liter (pmol/L) | 95% CI |
|---|---|---|
| 1.5 mg LY218926526 Weeks (n=238, 249, 230, 115) | 11.59 | - |
| 52 Weeks (n=207, 218, 200) | 10.57 | - |
| 104 Weeks (n=187, 200, 183) | 11.36 | - |
| 0.75 mg LY218926526 Weeks (n=238, 249, 230, 115) | 10.15 | - |
| 52 Weeks (n=207, 218, 200) | 12.95 | - |
| 104 Weeks (n=187, 200, 183) | 21.56 | - |
| Sitagliptin26 Weeks (n=238, 249, 230, 115) | 8.48 | - |
| 52 Weeks (n=207, 218, 200) | 4.18 | - |
| 104 Weeks (n=187, 200, 183) | 0.29 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)26 Weeks (n=238, 249, 230, 115) | -6.92 | - |
| 52 Weeks (n=207, 218, 200) | NA | - |
| 104 Weeks (n=187, 200, 183) | NA | - |
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Time frame:Baseline, 26, 52, and 104 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Number · percentage of participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265<7.0% at 26 Weeks | 60.9 | - |
| <7.0% at 52 Weeks | 57.6 | - |
| <7.0% at 104 Weeks | 54.3 | - |
| ≤6.5% at 26 Weeks | 46.7 | - |
| ≤6.5% at 52 Weeks | 41.7 | - |
| ≤6.5% at 104 Weeks | 39.1 | - |
| 0.75 mg LY2189265<7.0% at 26 Weeks | 55.2 | - |
| <7.0% at 52 Weeks | 48.8 | - |
| <7.0% at 104 Weeks | 44.8 | - |
| ≤6.5% at 26 Weeks | 31.0 | - |
| ≤6.5% at 52 Weeks | 29.0 | - |
| ≤6.5% at 104 Weeks | 24.2 | - |
| Sitagliptin<7.0% at 26 Weeks | 37.8 | - |
| <7.0% at 52 Weeks | 33.0 | - |
| <7.0% at 104 Weeks | 31.1 | - |
| ≤6.5% at 26 Weeks | 21.8 | - |
| ≤6.5% at 52 Weeks | 19.2 | - |
| ≤6.5% at 104 Weeks | 14.1 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)<7.0% at 26 Weeks | 21.0 | - |
| <7.0% at 52 Weeks | NA | - |
| <7.0% at 104 Weeks | NA | - |
| ≤6.5% at 26 Weeks | 12.5 | - |
| ≤6.5% at 52 Weeks | NA | - |
| ≤6.5% at 104 Weeks | NA | - |
Beta Cell Function and Insulin Sensitivity (HOMA2)
Time frame:Baseline, 26, 52, and 104 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Least-squares mean · HOMA2-% | 95% CI |
|---|---|---|
| 1.5 mg LY2189265HOMA2-%B, 26 Weeks (n=206, 226, 206, 84) | 32.28 | - |
| HOMA2-%B, 52 Weeks (n=188, 198, 180) | 33.57 | - |
| HOMA2-%B, 104 Weeks (n=148, 154, 134) | 30.89 | - |
| HOMA2-%S, 26 Weeks (n=206, 226, 206, 84) | 5.75 | - |
| HOMA2-%S, 52 Weeks (n=188, 198, 180) | 4.69 | - |
| HOMA2-%S, 104 Weeks (n=148, 154, 134) | 3.82 | - |
| 0.75 mg LY2189265HOMA2-%B, 26 Weeks (n=206, 226, 206, 84) | 26.98 | - |
| HOMA2-%B, 52 Weeks (n=188, 198, 180) | 22.30 | - |
| HOMA2-%B, 104 Weeks (n=148, 154, 134) | 19.11 | - |
| HOMA2-%S, 26 Weeks (n=206, 226, 206, 84) | 0.78 | - |
| HOMA2-%S, 52 Weeks (n=188, 198, 180) | 2.28 | - |
| HOMA2-%S, 104 Weeks (n=148, 154, 134) | -0.12 | - |
| SitagliptinHOMA2-%B, 26 Weeks (n=206, 226, 206, 84) | 10.81 | - |
| HOMA2-%B, 52 Weeks (n=188, 198, 180) | 6.66 | - |
| HOMA2-%B, 104 Weeks (n=148, 154, 134) | 1.47 | - |
| HOMA2-%S, 26 Weeks (n=206, 226, 206, 84) | 2.29 | - |
| HOMA2-%S, 52 Weeks (n=188, 198, 180) | 4.25 | - |
| HOMA2-%S, 104 Weeks (n=148, 154, 134) | 5.61 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)HOMA2-%B, 26 Weeks (n=206, 226, 206, 84) | 1.60 | - |
| HOMA2-%B, 52 Weeks (n=188, 198, 180) | NA | - |
| HOMA2-%B, 104 Weeks (n=148, 154, 134) | NA | - |
| HOMA2-%S, 26 Weeks (n=206, 226, 206, 84) | 9.82 | - |
| HOMA2-%S, 52 Weeks (n=188, 198, 180) | NA | - |
| HOMA2-%S, 104 Weeks (n=148, 154, 134) | NA | - |
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point
Time frame:Baseline up to 27.4 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Glycosylated Hemoglobin (HbA1c) Change From Baseline
Time frame:Baseline, 26 weeks, 104 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame:Baseline, 13, 26, 52, and 104 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Fasting Blood Glucose Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Fasting Insulin Change From Baseline
Time frame:Baseline, 26, 52, and 104 weeks
change from baseline, improvement
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Time frame:Baseline, 26, 52, and 104 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement
LOINC 4548-4
Beta Cell Function and Insulin Sensitivity (HOMA2)
Time frame:Baseline, 26, 52, and 104 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Cardiometabolic biomarkers
8 endpointsChange From Baseline in Pulse Rate at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Mean · beats per minute (bpm) | 95% CI |
|---|---|---|
| 3.0 mg LY2189265 | 6.63 | - |
| 2.0 mg LY2189265 | 3.43 | - |
| 1.5 mg LY2189265 | 2.39 | - |
| 1.0 mg LY2189265 | 3.34 | - |
| 0.75 mg LY2189265 | -1.63 | - |
| 0.5 mg LY2189265 | 1.91 | - |
| 0.25 mg LY2189265 | 1.05 | - |
| Sitagliptin | -0.16 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks) | 1.81 | - |
Change From Baseline in Blood Pressure at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
change from baseline, improvement
Posted result
| Group | Mean · millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| 3.0 mg LY2189265Sitting SBP | -8.85 | - |
| Sitting DBP | -1.21 | - |
| 2.0 mg LY2189265Sitting SBP | -4.63 | - |
| Sitting DBP | -1.17 | - |
| 1.5 mg LY2189265Sitting SBP | -4.77 | - |
| Sitting DBP | -1.20 | - |
| 1.0 mg LY2189265Sitting SBP | -2.00 | - |
| Sitting DBP | -0.08 | - |
| 0.75 mg LY2189265Sitting SBP | -6.21 | - |
| Sitting DBP | -3.18 | - |
| 0.5 mg LY2189265Sitting SBP | 0.40 | - |
| Sitting DBP | -0.75 | - |
| 0.25 mg LY2189265Sitting SBP | 1.67 | - |
| Sitting DBP | 1.28 | - |
| SitagliptinSitting SBP | -2.16 | - |
| Sitting DBP | -1.11 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Sitting SBP | -0.61 | - |
| Sitting DBP | -0.22 | - |
Change From Baseline in Pulse Rate
Time frame:Baseline, 26 weeks, 104 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Least-squares mean · beats per minute (bpm) | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Sitting, 26 Weeks (n=271, 278, 283, 138) | 2.57 | - |
| Sitting, 104 Weeks (n=197, 192, 191) | 2.28 | - |
| Standing, 26 Weeks (n=271, 277, 281, 138) | 3.24 | - |
| Standing, 104 Weeks (n=197, 192, 191) | 2.26 | - |
| 0.75 mg LY2189265Sitting, 26 Weeks (n=271, 278, 283, 138) | 1.90 | - |
| Sitting, 104 Weeks (n=197, 192, 191) | 2.77 | - |
| Standing, 26 Weeks (n=271, 277, 281, 138) | 2.00 | - |
| Standing, 104 Weeks (n=197, 192, 191) | 2.50 | - |
| SitagliptinSitting, 26 Weeks (n=271, 278, 283, 138) | -0.11 | - |
| Sitting, 104 Weeks (n=197, 192, 191) | -0.78 | - |
| Standing, 26 Weeks (n=271, 277, 281, 138) | -0.24 | - |
| Standing, 104 Weeks (n=197, 192, 191) | -1.06 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Sitting, 26 Weeks (n=271, 278, 283, 138) | -0.22 | - |
| Sitting, 104 Weeks (n=197, 192, 191) | NA | - |
| Standing, 26 Weeks (n=271, 277, 281, 138) | -0.17 | - |
| Standing, 104 Weeks (n=197, 192, 191) | NA | - |
Change From Baseline in Blood Pressure
Time frame:Baseline, 26 weeks, 104 weeks
change from baseline, improvement
Posted result
| Group | Least-squares mean · millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Sitting SBP, 26 Weeks (n=271, 278, 283, 138) | -1.73 | - |
| Sitting SBP, 104 Weeks (n=197, 192, 191) | -0.07 | - |
| Sitting DBP, 26 Weeks (n=271, 278, 283, 138) | -0.43 | - |
| Sitting DBP, 104 Weeks (n=197, 192, 191) | 0.38 | - |
| Standing SBP, 26 Weeks (n=271, 277, 281, 138) | -1.53 | - |
| Standing SBP, 104 Weeks (n=197, 192, 191) | -1.30 | - |
| Standing DBP, 26 Weeks (n=271, 277, 281, 138) | -0.11 | - |
| Standing DBP, 104 Weeks (n=197, 192, 191) | -0.23 | - |
| 0.75 mg LY2189265Sitting SBP, 26 Weeks (n=271, 278, 283, 138) | -1.40 | - |
| Sitting SBP, 104 Weeks (n=197, 192, 191) | 1.28 | - |
| Sitting DBP, 26 Weeks (n=271, 278, 283, 138) | -0.20 | - |
| Sitting DBP, 104 Weeks (n=197, 192, 191) | 1.40 | - |
| Standing SBP, 26 Weeks (n=271, 277, 281, 138) | -1.72 | - |
| Standing SBP, 104 Weeks (n=197, 192, 191) | 0.17 | - |
| Standing DBP, 26 Weeks (n=271, 277, 281, 138) | 0.03 | - |
| Standing DBP, 104 Weeks (n=197, 192, 191) | 0.36 | - |
| SitagliptinSitting SBP, 26 Weeks (n=271, 278, 283, 138) | -1.94 | - |
| Sitting SBP, 104 Weeks (n=197, 192, 191) | 0.02 | - |
| Sitting DBP, 26 Weeks (n=271, 278, 283, 138) | -1.06 | - |
| Sitting DBP, 104 Weeks (n=197, 192, 191) | -0.36 | - |
| Standing SBP, 26 Weeks (n=271, 277, 281, 138) | -2.54 | - |
| Standing SBP, 104 Weeks (n=197, 192, 191) | -1.20 | - |
| Standing DBP, 26 Weeks (n=271, 277, 281, 138) | -1.36 | - |
| Standing DBP, 104 Weeks (n=197, 192, 191) | -0.67 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Sitting SBP, 26 Weeks (n=271, 278, 283, 138) | 1.12 | - |
| Sitting SBP, 104 Weeks (n=197, 192, 191) | NA | - |
| Sitting DBP, 26 Weeks (n=271, 278, 283, 138) | 0.68 | - |
| Sitting DBP, 104 Weeks (n=197, 192, 191) | NA | - |
| Standing SBP, 26 Weeks (n=271, 277, 281, 138) | 0.26 | - |
| Standing SBP, 104 Weeks (n=197, 192, 191) | NA | - |
| Standing DBP, 26 Weeks (n=271, 277, 281, 138) | -0.52 | - |
| Standing DBP, 104 Weeks (n=197, 192, 191) | NA | - |
Change From Baseline in Pulse Rate at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
Heart rate, change
change from baseline, improvement
Change From Baseline in Blood Pressure at Dose Decision Point
Time frame:Baseline up to 27.4 weeks
change from baseline, improvement
Change From Baseline in Pulse Rate
Time frame:Baseline, 26 weeks, 104 weeks
Heart rate, change
change from baseline, improvement
Change From Baseline in Blood Pressure
Time frame:Baseline, 26 weeks, 104 weeks
change from baseline, improvement
Patient-reported / QoL
4 endpointsParticipant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)
Time frame:Baseline, 52 weeks, and 104 weeks
IWQOL-Lite total
change from baseline, improvement
Posted result
| Group | Mean · units on a scale | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Total Score, Baseline (n=285, 284, 300) | 83.41 | - |
| Total Score, 52 Weeks (n=237, 252, 247) | 86.92 | - |
| Total Score, 104 Weeks (n=190, 190, 185) | 88.08 | - |
| 0.75 mg LY2189265Total Score, Baseline (n=285, 284, 300) | 82.55 | - |
| Total Score, 52 Weeks (n=237, 252, 247) | 86.31 | - |
| Total Score, 104 Weeks (n=190, 190, 185) | 87.47 | - |
| SitagliptinTotal Score, Baseline (n=285, 284, 300) | 83.97 | - |
| Total Score, 52 Weeks (n=237, 252, 247) | 86.25 | - |
| Total Score, 104 Weeks (n=190, 190, 185) | 86.93 | - |
Participant-reported Outcomes, EQ-5D
Time frame:Baseline, 52 weeks, and 104 weeks
EQ-5D index
change from baseline, improvement
Posted result
| Group | Mean · units on a scale | 95% CI |
|---|---|---|
| 1.5 mg LY2189265EQ-5D, UK, Baseline (n=285, 281, 300) | 0.80 | - |
| EQ-5D, UK, 52 Weeks (n=237, 250, 244) | 0.83 | - |
| EQ-5D, UK, 104 Weeks (n=189, 190, 185) | 0.84 | - |
| VAS, Baseline (n=285, 284, 301) | 75.57 | - |
| VAS, 52 Weeks (n=238, 251, 245) | 78.93 | - |
| VAS, 104 Weeks (n=189, 190, 185) | 79.66 | - |
| 0.75 mg LY2189265EQ-5D, UK, Baseline (n=285, 281, 300) | 0.82 | - |
| EQ-5D, UK, 52 Weeks (n=237, 250, 244) | 0.84 | - |
| EQ-5D, UK, 104 Weeks (n=189, 190, 185) | 0.86 | - |
| VAS, Baseline (n=285, 284, 301) | 75.35 | - |
| VAS, 52 Weeks (n=238, 251, 245) | 78.22 | - |
| VAS, 104 Weeks (n=189, 190, 185) | 78.52 | - |
| SitagliptinEQ-5D, UK, Baseline (n=285, 281, 300) | 0.84 | - |
| EQ-5D, UK, 52 Weeks (n=237, 250, 244) | 0.85 | - |
| EQ-5D, UK, 104 Weeks (n=189, 190, 185) | 0.86 | - |
| VAS, Baseline (n=285, 284, 301) | 76.85 | - |
| VAS, 52 Weeks (n=238, 251, 245) | 78.79 | - |
| VAS, 104 Weeks (n=189, 190, 185) | 81.34 | - |
Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)
Time frame:Baseline, 52 weeks, and 104 weeks
IWQOL-Lite total
change from baseline, improvement
Participant-reported Outcomes, EQ-5D
Time frame:Baseline, 52 weeks, and 104 weeks
EQ-5D index
change from baseline, improvement
Safety / tolerability / PK
26 endpointsIncidence of Hypoglycemic Episodes
Time frame:Baseline through 26 and 104 weeks
Documented hypoglycemia
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Severe HE, 26 Weeks | 0 | - |
| Severe HE, 104 Weeks | 0 | - |
| Documented Symptomatic HE, 26 Weeks | 17 | - |
| Documented Symptomatic HE, 104 Weeks | 33 | - |
| Asymptomatic HE, 26 Weeks | 5 | - |
| Asymptomatic HE, 104 Weeks | 9 | - |
| Nocturnal HE, 26 Weeks | 7 | - |
| Nocturnal HE, 104 Weeks | 14 | - |
| Probable HE, 26 Weeks | 5 | - |
| Probable HE, 104 Weeks | 6 | - |
| 0.75 mg LY2189265Severe HE, 26 Weeks | 0 | - |
| Severe HE, 104 Weeks | 0 | - |
| Documented Symptomatic HE, 26 Weeks | 8 | - |
| Documented Symptomatic HE, 104 Weeks | 19 | - |
| Asymptomatic HE, 26 Weeks | 5 | - |
| Asymptomatic HE, 104 Weeks | 9 | - |
| Nocturnal HE, 26 Weeks | 5 | - |
| Nocturnal HE, 104 Weeks | 13 | - |
| Probable HE, 26 Weeks | 0 | - |
| Probable HE, 104 Weeks | 2 | - |
| SitagliptinSevere HE, 26 Weeks | 0 | - |
| Severe HE, 104 Weeks | 0 | - |
| Documented Symptomatic HE, 26 Weeks | 10 | - |
| Documented Symptomatic HE, 104 Weeks | 18 | - |
| Asymptomatic HE, 26 Weeks | 0 | - |
| Asymptomatic HE, 104 Weeks | 3 | - |
| Nocturnal HE, 26 Weeks | 2 | - |
| Nocturnal HE, 104 Weeks | 10 | - |
| Probable HE, 26 Weeks | 2 | - |
| Probable HE, 104 Weeks | 6 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Severe HE, 26 Weeks | 0 | - |
| Severe HE, 104 Weeks | NA | - |
| Documented Symptomatic HE, 26 Weeks | 2 | - |
| Documented Symptomatic HE, 104 Weeks | NA | - |
| Asymptomatic HE, 26 Weeks | 0 | - |
| Asymptomatic HE, 104 Weeks | NA | - |
| Nocturnal HE, 26 Weeks | 0 | - |
| Nocturnal HE, 104 Weeks | NA | - |
| Probable HE, 26 Weeks | 0 | - |
| Probable HE, 104 Weeks | NA | - |
Rate of Hypoglycemic Episodes
Time frame:Baseline through 26 and 104 weeks
Documented hypoglycemia
event count, event
Posted result
| Group | Mean · episodes per participant per year | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Severe HE, 26 Weeks | 0.0 | - |
| Severe HE, 104 Weeks | 0.0 | - |
| Documented Symptomatic HE, 26 Weeks | 0.3 | - |
| Documented Symptomatic HE, 104 Weeks | 0.2 | - |
| Asymptomatic HE, 26 Weeks | 0.1 | - |
| Asymptomatic HE, 104 Weeks | 0.1 | - |
| Nocturnal HE, 26 Weeks | 0.1 | - |
| Nocturnal HE, 104 Weeks | 0.1 | - |
| Probable Symptomatic HE, 26 Weeks | 0.0 | - |
| Probable Symptomatic HE, 104 Weeks | 0.0 | - |
| 0.75 mg LY2189265Severe HE, 26 Weeks | 0.0 | - |
| Severe HE, 104 Weeks | 0.0 | - |
| Documented Symptomatic HE, 26 Weeks | 0.1 | - |
| Documented Symptomatic HE, 104 Weeks | 0.2 | - |
| Asymptomatic HE, 26 Weeks | 0.1 | - |
| Asymptomatic HE, 104 Weeks | 0.0 | - |
| Nocturnal HE, 26 Weeks | 0.1 | - |
| Nocturnal HE, 104 Weeks | 0.0 | - |
| Probable Symptomatic HE, 26 Weeks | 0.0 | - |
| Probable Symptomatic HE, 104 Weeks | 0.0 | - |
| SitagliptinSevere HE, 26 Weeks | 0.0 | - |
| Severe HE, 104 Weeks | 0.0 | - |
| Documented Symptomatic HE, 26 Weeks | 0.1 | - |
| Documented Symptomatic HE, 104 Weeks | 0.2 | - |
| Asymptomatic HE, 26 Weeks | 0.0 | - |
| Asymptomatic HE, 104 Weeks | 0.0 | - |
| Nocturnal HE, 26 Weeks | 0.0 | - |
| Nocturnal HE, 104 Weeks | 0.1 | - |
| Probable Symptomatic HE, 26 Weeks | 0.0 | - |
| Probable Symptomatic HE, 104 Weeks | 0.0 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Severe HE, 26 Weeks | 0.0 | - |
| Severe HE, 104 Weeks | NA | - |
| Documented Symptomatic HE, 26 Weeks | 0.1 | - |
| Documented Symptomatic HE, 104 Weeks | NA | - |
| Asymptomatic HE, 26 Weeks | 0.0 | - |
| Asymptomatic HE, 104 Weeks | NA | - |
| Nocturnal HE, 26 Weeks | 0.0 | - |
| Nocturnal HE, 104 Weeks | NA | - |
| Probable Symptomatic HE, 26 Weeks | 0.0 | - |
| Probable Symptomatic HE, 104 Weeks | NA | - |
Number of Participants With Treatment-emergent Adverse Events at 26 Weeks
Time frame:Baseline through 26 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265 | 208 | - |
| 0.75 mg LY2189265 | 204 | - |
| Sitagliptin | 185 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks) | 111 | - |
Number of Participants With Treatment-emergent Adverse Events at 52 Weeks
Time frame:Baseline through 52 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 3.0 mg LY2189265 | 9 | - |
| 2.0 mg LY2189265 | 20 | - |
| 1.5 mg LY2189265 | 233 | - |
| 1.0 mg LY2189265 | 8 | - |
| 0.75 mg LY2189265 | 231 | - |
| 0.5 mg LY2189265 | 15 | - |
| 0.25 mg LY2189265 | 10 | - |
| Sitagliptin | 219 | - |
Number of Participants With Treatment-emergent Adverse Events at 104 Weeks
Time frame:Baseline through 104 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265 | 259 | - |
| 0.75 mg LY2189265 | 255 | - |
| Sitagliptin | 242 | - |
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks
Time frame:Baseline through 26 weeks
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Alkaline Phosphatase (n=276, 258, 281, 162) | 9 | - |
| ALT/SGPT (n=232, 237, 244, 128) | 18 | - |
| Amylase Pancreatic, High (n=283, 277, 295, 160) | 54 | - |
| Amylase Total (n=266, 265, 277, 143) | 33 | - |
| AST/SGOT (n=273, 269, 284, 148) | 14 | - |
| Basophils, High (n=268, 259, 278, 163) | 1 | - |
| Basophils, Low (n=269, 259, 278, 163) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307, 171) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305, 168) | 2 | - |
| Calcitonin, High (n=226, 233, 230, 113) | 1 | - |
| Chloride, High (n=299, 293, 310, 174) | 0 | - |
| Chloride, Low (n=299, 293, 308, 174) | 1 | - |
| CPK, High (n=273, 262, 276, 156 | 29 | - |
| Creatinine, High (n=294, 285, 303, 172) | 7 | - |
| Creatinine Clearance, High (n=164, 186, 180, 107) | 17 | - |
| Creatinine Clearance, Low (n=292, 278,303,168) | 11 | - |
| Eosinophils, High (n=258, 256, 275, 157) | 4 | - |
| Eosinophils, Low (n=269, 259, 278, 163) | 0 | - |
| Erythrocyte Count, High (n=279, 272, 287, 164) | 1 | - |
| Erythrocyte Count, Low (n=274, 268, 280, 161) | 12 | - |
| GGT, High (n=234, 240, 245, 144) | 9 | - |
| Hematocrit, High (n=273, 265, 279, 161) | 1 | - |
| Hematocrit, Low (n=256, 242, 259, 157) | 13 | - |
| Hemoglobin, High (n=278, 271, 289, 164) | 1 | - |
| Hemoglobin, Low (n=262, 249, 265, 162) | 13 | - |
| Leukocyte Count, High (n=272, 265, 286, 165) | 3 | - |
| Leukocyte Count, Low (n=272, 262, 280, 165) | 2 | - |
| Lipase, High (n=255, 248, 269, 147) | 109 | - |
| Lymphocytes, High (n=249, 253, 269, 161) | 5 | - |
| Lymphocytes, Low (n=265, 258, 273, 159) | 3 | - |
| MCHC, High (n=274, 265, 280, 163) | 0 | - |
| MCHC, Low (n=273, 263, 279, 163) | 0 | - |
| MCV, High (n=261, 248, 263, 156) | 19 | - |
| MCV, Low (n=264, 252, 275, 162) | 3 | - |
| Monocytes, High (n=266, 258, 274, 163) | 1 | - |
| Monocytes, Low (n=265, 255, 274, 158) | 6 | - |
| Neutrophils, High (n=264, 255, 276, 161) | 4 | - |
| Neutrophils, Low (n=263, 251, 271, 162) | 2 | - |
| Platelet Count, High (n=265, 260, 281, 160) | 0 | - |
| Platelet Count, Low (n=262, 252, 269, 154) | 2 | - |
| Potassium, High (n=297, 291, 307, 172) | 7 | - |
| Potassium, Low (n=298, 293, 308, 169) | 4 | - |
| Sodium, High (n=291, 291, 307, 170) | 3 | - |
| Sodium, Low (n=298, 292, 305, 174) | 2 | - |
| Urea Nitrogen, High (n=287, 282, 305, 169) | 11 | - |
| UMCR, High (n=217, 204, 232, 130) | 18 | - |
| 0.75 mg LY2189265Alkaline Phosphatase (n=276, 258, 281, 162) | 3 | - |
| ALT/SGPT (n=232, 237, 244, 128) | 24 | - |
| Amylase Pancreatic, High (n=283, 277, 295, 160) | 55 | - |
| Amylase Total (n=266, 265, 277, 143) | 33 | - |
| AST/SGOT (n=273, 269, 284, 148) | 12 | - |
| Basophils, High (n=268, 259, 278, 163) | 0 | - |
| Basophils, Low (n=269, 259, 278, 163) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307, 171) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305, 168) | 4 | - |
| Calcitonin, High (n=226, 233, 230, 113) | 2 | - |
| Chloride, High (n=299, 293, 310, 174) | 1 | - |
| Chloride, Low (n=299, 293, 308, 174) | 2 | - |
| CPK, High (n=273, 262, 276, 156 | 20 | - |
| Creatinine, High (n=294, 285, 303, 172) | 10 | - |
| Creatinine Clearance, High (n=164, 186, 180, 107) | 28 | - |
| Creatinine Clearance, Low (n=292, 278,303,168) | 17 | - |
| Eosinophils, High (n=258, 256, 275, 157) | 11 | - |
| Eosinophils, Low (n=269, 259, 278, 163) | 0 | - |
| Erythrocyte Count, High (n=279, 272, 287, 164) | 1 | - |
| Erythrocyte Count, Low (n=274, 268, 280, 161) | 7 | - |
| GGT, High (n=234, 240, 245, 144) | 11 | - |
| Hematocrit, High (n=273, 265, 279, 161) | 1 | - |
| Hematocrit, Low (n=256, 242, 259, 157) | 10 | - |
| Hemoglobin, High (n=278, 271, 289, 164) | 1 | - |
| Hemoglobin, Low (n=262, 249, 265, 162) | 16 | - |
| Leukocyte Count, High (n=272, 265, 286, 165) | 6 | - |
| Leukocyte Count, Low (n=272, 262, 280, 165) | 3 | - |
| Lipase, High (n=255, 248, 269, 147) | 92 | - |
| Lymphocytes, High (n=249, 253, 269, 161) | 9 | - |
| Lymphocytes, Low (n=265, 258, 273, 159) | 3 | - |
| MCHC, High (n=274, 265, 280, 163) | 0 | - |
| MCHC, Low (n=273, 263, 279, 163) | 2 | - |
| MCV, High (n=261, 248, 263, 156) | 12 | - |
| MCV, Low (n=264, 252, 275, 162) | 2 | - |
| Monocytes, High (n=266, 258, 274, 163) | 0 | - |
| Monocytes, Low (n=265, 255, 274, 158) | 5 | - |
| Neutrophils, High (n=264, 255, 276, 161) | 5 | - |
| Neutrophils, Low (n=263, 251, 271, 162) | 1 | - |
| Platelet Count, High (n=265, 260, 281, 160) | 0 | - |
| Platelet Count, Low (n=262, 252, 269, 154) | 3 | - |
| Potassium, High (n=297, 291, 307, 172) | 2 | - |
| Potassium, Low (n=298, 293, 308, 169) | 6 | - |
| Sodium, High (n=291, 291, 307, 170) | 4 | - |
| Sodium, Low (n=298, 292, 305, 174) | 1 | - |
| Urea Nitrogen, High (n=287, 282, 305, 169) | 17 | - |
| UMCR, High (n=217, 204, 232, 130) | 9 | - |
| SitagliptinAlkaline Phosphatase (n=276, 258, 281, 162) | 12 | - |
| ALT/SGPT (n=232, 237, 244, 128) | 25 | - |
| Amylase Pancreatic, High (n=283, 277, 295, 160) | 42 | - |
| Amylase Total (n=266, 265, 277, 143) | 27 | - |
| AST/SGOT (n=273, 269, 284, 148) | 18 | - |
| Basophils, High (n=268, 259, 278, 163) | 1 | - |
| Basophils, Low (n=269, 259, 278, 163) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307, 171) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305, 168) | 4 | - |
| Calcitonin, High (n=226, 233, 230, 113) | 2 | - |
| Chloride, High (n=299, 293, 310, 174) | 0 | - |
| Chloride, Low (n=299, 293, 308, 174) | 1 | - |
| CPK, High (n=273, 262, 276, 156 | 30 | - |
| Creatinine, High (n=294, 285, 303, 172) | 5 | - |
| Creatinine Clearance, High (n=164, 186, 180, 107) | 26 | - |
| Creatinine Clearance, Low (n=292, 278,303,168) | 12 | - |
| Eosinophils, High (n=258, 256, 275, 157) | 6 | - |
| Eosinophils, Low (n=269, 259, 278, 163) | 0 | - |
| Erythrocyte Count, High (n=279, 272, 287, 164) | 0 | - |
| Erythrocyte Count, Low (n=274, 268, 280, 161) | 7 | - |
| GGT, High (n=234, 240, 245, 144) | 23 | - |
| Hematocrit, High (n=273, 265, 279, 161) | 1 | - |
| Hematocrit, Low (n=256, 242, 259, 157) | 6 | - |
| Hemoglobin, High (n=278, 271, 289, 164) | 1 | - |
| Hemoglobin, Low (n=262, 249, 265, 162) | 5 | - |
| Leukocyte Count, High (n=272, 265, 286, 165) | 1 | - |
| Leukocyte Count, Low (n=272, 262, 280, 165) | 4 | - |
| Lipase, High (n=255, 248, 269, 147) | 97 | - |
| Lymphocytes, High (n=249, 253, 269, 161) | 6 | - |
| Lymphocytes, Low (n=265, 258, 273, 159) | 4 | - |
| MCHC, High (n=274, 265, 280, 163) | 0 | - |
| MCHC, Low (n=273, 263, 279, 163) | 0 | - |
| MCV, High (n=261, 248, 263, 156) | 14 | - |
| MCV, Low (n=264, 252, 275, 162) | 2 | - |
| Monocytes, High (n=266, 258, 274, 163) | 3 | - |
| Monocytes, Low (n=265, 255, 274, 158) | 8 | - |
| Neutrophils, High (n=264, 255, 276, 161) | 3 | - |
| Neutrophils, Low (n=263, 251, 271, 162) | 2 | - |
| Platelet Count, High (n=265, 260, 281, 160) | 1 | - |
| Platelet Count, Low (n=262, 252, 269, 154) | 6 | - |
| Potassium, High (n=297, 291, 307, 172) | 5 | - |
| Potassium, Low (n=298, 293, 308, 169) | 3 | - |
| Sodium, High (n=291, 291, 307, 170) | 4 | - |
| Sodium, Low (n=298, 292, 305, 174) | 4 | - |
| Urea Nitrogen, High (n=287, 282, 305, 169) | 13 | - |
| UMCR, High (n=217, 204, 232, 130) | 13 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Alkaline Phosphatase (n=276, 258, 281, 162) | 3 | - |
| ALT/SGPT (n=232, 237, 244, 128) | 8 | - |
| Amylase Pancreatic, High (n=283, 277, 295, 160) | 18 | - |
| Amylase Total (n=266, 265, 277, 143) | 13 | - |
| AST/SGOT (n=273, 269, 284, 148) | 7 | - |
| Basophils, High (n=268, 259, 278, 163) | 0 | - |
| Basophils, Low (n=269, 259, 278, 163) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307, 171) | 2 | - |
| Bilirubin Total, High (n=295, 290, 305, 168) | 1 | - |
| Calcitonin, High (n=226, 233, 230, 113) | 0 | - |
| Chloride, High (n=299, 293, 310, 174) | 0 | - |
| Chloride, Low (n=299, 293, 308, 174) | 1 | - |
| CPK, High (n=273, 262, 276, 156 | 7 | - |
| Creatinine, High (n=294, 285, 303, 172) | 5 | - |
| Creatinine Clearance, High (n=164, 186, 180, 107) | 25 | - |
| Creatinine Clearance, Low (n=292, 278,303,168) | 6 | - |
| Eosinophils, High (n=258, 256, 275, 157) | 2 | - |
| Eosinophils, Low (n=269, 259, 278, 163) | 0 | - |
| Erythrocyte Count, High (n=279, 272, 287, 164) | 0 | - |
| Erythrocyte Count, Low (n=274, 268, 280, 161) | 3 | - |
| GGT, High (n=234, 240, 245, 144) | 10 | - |
| Hematocrit, High (n=273, 265, 279, 161) | 2 | - |
| Hematocrit, Low (n=256, 242, 259, 157) | 5 | - |
| Hemoglobin, High (n=278, 271, 289, 164) | 2 | - |
| Hemoglobin, Low (n=262, 249, 265, 162) | 3 | - |
| Leukocyte Count, High (n=272, 265, 286, 165) | 0 | - |
| Leukocyte Count, Low (n=272, 262, 280, 165) | 1 | - |
| Lipase, High (n=255, 248, 269, 147) | 37 | - |
| Lymphocytes, High (n=249, 253, 269, 161) | 3 | - |
| Lymphocytes, Low (n=265, 258, 273, 159) | 2 | - |
| MCHC, High (n=274, 265, 280, 163) | 0 | - |
| MCHC, Low (n=273, 263, 279, 163) | 0 | - |
| MCV, High (n=261, 248, 263, 156) | 5 | - |
| MCV, Low (n=264, 252, 275, 162) | 0 | - |
| Monocytes, High (n=266, 258, 274, 163) | 1 | - |
| Monocytes, Low (n=265, 255, 274, 158) | 10 | - |
| Neutrophils, High (n=264, 255, 276, 161) | 1 | - |
| Neutrophils, Low (n=263, 251, 271, 162) | 1 | - |
| Platelet Count, High (n=265, 260, 281, 160) | 0 | - |
| Platelet Count, Low (n=262, 252, 269, 154) | 3 | - |
| Potassium, High (n=297, 291, 307, 172) | 4 | - |
| Potassium, Low (n=298, 293, 308, 169) | 1 | - |
| Sodium, High (n=291, 291, 307, 170) | 4 | - |
| Sodium, Low (n=298, 292, 305, 174) | 1 | - |
| Urea Nitrogen, High (n=287, 282, 305, 169) | 5 | - |
| UMCR, High (n=217, 204, 232, 130) | 5 | - |
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks
Time frame:Baseline through 52 weeks
descriptive
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Alkaline Phosphatase, High (n=276, 258, 281) | 10 | - |
| ALT/SGPT, High (n=232, 237, 244) | 25 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 67 | - |
| Amylase Total, High (n=266, 265, 277) | 38 | - |
| AST/SGOT, High (n=273, 269, 284) | 15 | - |
| Basophils, High (n=276, 268, 287) | 1 | - |
| Basophils, Low (n=277, 268, 287) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305) | 2 | - |
| Calcitonin, High (n=233, 239, 235) | 4 | - |
| Chloride, High (n=299, 293, 310) | 0 | - |
| Chloride, Low (n=299, 293, 308) | 1 | - |
| CPK, High (n=273, 262, 276) | 38 | - |
| Creatinine, High (n=294, 285, 303) | 9 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 23 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 18 | - |
| Eosinophils, High (n=265, 265, 283) | 11 | - |
| Eosinophils, Low (n=277, 268, 287) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 3 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 15 | - |
| GGT, High (n=234, 240, 245) | 10 | - |
| Hematocrit, High (n=280, 274, 290) | 3 | - |
| Hematocrit, Low (n=262, 251, 269) | 21 | - |
| Hemoglobin, High (n=282, 275, 294) | 3 | - |
| Hemoglobin, Low (n=265, 253, 269) | 21 | - |
| Leukocyte Count, High (n=277, 270, 292) | 7 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 5 | - |
| Lipase, High (n=255, 248, 269) | 124 | - |
| Lymphocytes, High (n=257, 262, 278) | 12 | - |
| Lymphocytes, Low (n=273, 266, 280) | 4 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 2 | - |
| MCV, High (n=267, 256, 273) | 25 | - |
| MCV, Low (n=270, 261, 286) | 3 | - |
| Monocytes, High (n=274, 267, 283) | 1 | - |
| Monocytes, Low (n=271, 264, 282) | 8 | - |
| Neutrophils, High (n=272, 263, 285) | 8 | - |
| Neutrophils, Low (n=271, 260, 279) | 6 | - |
| Platelet Count, High (n=272, 267, 287) | 0 | - |
| Platelet Count, Low (n=269, 259, 275) | 4 | - |
| Potassium, High (n=297, 291, 307) | 10 | - |
| Potassium, Low (n=298, 293, 308) | 6 | - |
| Sodium, High (n=291, 291, 307) | 5 | - |
| Sodium, Low (n=298, 292, 305) | 3 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 14 | - |
| UMCR, High (n=223, 212, 238) | 33 | - |
| 0.75 mg LY2189265Alkaline Phosphatase, High (n=276, 258, 281) | 6 | - |
| ALT/SGPT, High (n=232, 237, 244) | 27 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 70 | - |
| Amylase Total, High (n=266, 265, 277) | 42 | - |
| AST/SGOT, High (n=273, 269, 284) | 19 | - |
| Basophils, High (n=276, 268, 287) | 0 | - |
| Basophils, Low (n=277, 268, 287) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305) | 6 | - |
| Calcitonin, High (n=233, 239, 235) | 2 | - |
| Chloride, High (n=299, 293, 310) | 1 | - |
| Chloride, Low (n=299, 293, 308) | 2 | - |
| CPK, High (n=273, 262, 276) | 28 | - |
| Creatinine, High (n=294, 285, 303) | 10 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 30 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 20 | - |
| Eosinophils, High (n=265, 265, 283) | 14 | - |
| Eosinophils, Low (n=277, 268, 287) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 1 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 9 | - |
| GGT, High (n=234, 240, 245) | 14 | - |
| Hematocrit, High (n=280, 274, 290) | 2 | - |
| Hematocrit, Low (n=262, 251, 269) | 13 | - |
| Hemoglobin, High (n=282, 275, 294) | 1 | - |
| Hemoglobin, Low (n=265, 253, 269) | 19 | - |
| Leukocyte Count, High (n=277, 270, 292) | 6 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 3 | - |
| Lipase, High (n=255, 248, 269) | 111 | - |
| Lymphocytes, High (n=257, 262, 278) | 15 | - |
| Lymphocytes, Low (n=273, 266, 280) | 4 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 3 | - |
| MCV, High (n=267, 256, 273) | 18 | - |
| MCV, Low (n=270, 261, 286) | 2 | - |
| Monocytes, High (n=274, 267, 283) | 0 | - |
| Monocytes, Low (n=271, 264, 282) | 9 | - |
| Neutrophils, High (n=272, 263, 285) | 7 | - |
| Neutrophils, Low (n=271, 260, 279) | 2 | - |
| Platelet Count, High (n=272, 267, 287) | 2 | - |
| Platelet Count, Low (n=269, 259, 275) | 5 | - |
| Potassium, High (n=297, 291, 307) | 5 | - |
| Potassium, Low (n=298, 293, 308) | 7 | - |
| Sodium, High (n=291, 291, 307) | 8 | - |
| Sodium, Low (n=298, 292, 305) | 1 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 19 | - |
| UMCR, High (n=223, 212, 238) | 21 | - |
| SitagliptinAlkaline Phosphatase, High (n=276, 258, 281) | 16 | - |
| ALT/SGPT, High (n=232, 237, 244) | 28 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 55 | - |
| Amylase Total, High (n=266, 265, 277) | 36 | - |
| AST/SGOT, High (n=273, 269, 284) | 25 | - |
| Basophils, High (n=276, 268, 287) | 1 | - |
| Basophils, Low (n=277, 268, 287) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 2 | - |
| Bilirubin Total, High (n=295, 290, 305) | 5 | - |
| Calcitonin, High (n=233, 239, 235) | 2 | - |
| Chloride, High (n=299, 293, 310) | 0 | - |
| Chloride, Low (n=299, 293, 308) | 2 | - |
| CPK, High (n=273, 262, 276) | 43 | - |
| Creatinine, High (n=294, 285, 303) | 6 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 29 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 15 | - |
| Eosinophils, High (n=265, 265, 283) | 10 | - |
| Eosinophils, Low (n=277, 268, 287) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 1 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 11 | - |
| GGT, High (n=234, 240, 245) | 34 | - |
| Hematocrit, High (n=280, 274, 290) | 2 | - |
| Hematocrit, Low (n=262, 251, 269) | 11 | - |
| Hemoglobin, High (n=282, 275, 294) | 1 | - |
| Hemoglobin, Low (n=265, 253, 269) | 11 | - |
| Leukocyte Count, High (n=277, 270, 292) | 3 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 9 | - |
| Lipase, High (n=255, 248, 269) | 110 | - |
| Lymphocytes, High (n=257, 262, 278) | 11 | - |
| Lymphocytes, Low (n=273, 266, 280) | 11 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 3 | - |
| MCV, High (n=267, 256, 273) | 19 | - |
| MCV, Low (n=270, 261, 286) | 4 | - |
| Monocytes, High (n=274, 267, 283) | 5 | - |
| Monocytes, Low (n=271, 264, 282) | 15 | - |
| Neutrophils, High (n=272, 263, 285) | 7 | - |
| Neutrophils, Low (n=271, 260, 279) | 6 | - |
| Platelet Count, High (n=272, 267, 287) | 2 | - |
| Platelet Count, Low (n=269, 259, 275) | 8 | - |
| Potassium, High (n=297, 291, 307) | 5 | - |
| Potassium, Low (n=298, 293, 308) | 5 | - |
| Sodium, High (n=291, 291, 307) | 4 | - |
| Sodium, Low (n=298, 292, 305) | 4 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 21 | - |
| UMCR, High (n=223, 212, 238) | 18 | - |
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks
Time frame:Baseline through 104 weeks
descriptive
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Alkaline Phosphate, High (n=276, 258, 281) | 13 | - |
| ALT/SGPT, High (n=232, 237, 244) | 29 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 81 | - |
| Amylase Total, High (n=266, 265, 277) | 44 | - |
| AST/SGOT, High (n=273, 269, 284) | 21 | - |
| Basophils, High (n=276, 268, 288) | 1 | - |
| Basophils, Low (n=277, 268, 288) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 2 | - |
| Bilirubin Total, High (n=295, 290, 305) | 3 | - |
| Calcitonin, High (n=233, 239, 235) | 5 | - |
| Chloride, High (n=299, 293, 310) | 0 | - |
| Chloride, Low (n=299, 293, 308) | 3 | - |
| CPK, High (n=273, 262, 276) | 52 | - |
| Creatinine, High (n=294, 285, 303) | 11 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 26 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 24 | - |
| Eosinophils, High (n=265, 265, 284) | 12 | - |
| Eosinophils, Low (n=277, 268, 288) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 3 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 18 | - |
| GGT, High (n=234, 240, 245) | 16 | - |
| Hematocrit, High (n=280, 274, 290) | 3 | - |
| Hematocrit, Low (n=262, 251, 269) | 30 | - |
| Hemoglobin, High (n=282, 275, 294) | 4 | - |
| Hemoglobin, Low (n=265, 253, 269) | 30 | - |
| Leukocyte Count, High (n=277, 270, 292) | 13 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 9 | - |
| Lipase, High (n=255, 248, 269) | 142 | - |
| Lymphocytes, High (n=257, 262, 279) | 19 | - |
| Lymphocytes, Low (n=273, 266, 281) | 5 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 5 | - |
| MCV, High (n=267, 256, 273) | 39 | - |
| MCV, Low (n=270, 261, 286) | 9 | - |
| Monocytes, High (n=274, 267, 284) | 3 | - |
| Monocytes, Low (n=271, 264, 283) | 10 | - |
| Neutrophils, High (n=272, 263, 286) | 15 | - |
| Neutrophils, Low (n=271, 260, 280) | 10 | - |
| Platelet Count, High (n=273, 268, 287) | 2 | - |
| Platelet Count, Low (n=270, 260, 275) | 8 | - |
| Potassium, High (n=297, 291, 307) | 14 | - |
| Potassium, Low (n=298, 293, 308) | 8 | - |
| Sodium, High (n=291, 291, 307) | 10 | - |
| Sodium, Low (n=298, 292, 305) | 5 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 17 | - |
| UMCR, High (n=223, 212, 239) | 38 | - |
| 0.75 mg LY2189265Alkaline Phosphate, High (n=276, 258, 281) | 11 | - |
| ALT/SGPT, High (n=232, 237, 244) | 37 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 78 | - |
| Amylase Total, High (n=266, 265, 277) | 55 | - |
| AST/SGOT, High (n=273, 269, 284) | 27 | - |
| Basophils, High (n=276, 268, 288) | 0 | - |
| Basophils, Low (n=277, 268, 288) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 1 | - |
| Bilirubin Total, High (n=295, 290, 305) | 8 | - |
| Calcitonin, High (n=233, 239, 235) | 3 | - |
| Chloride, High (n=299, 293, 310) | 2 | - |
| Chloride, Low (n=299, 293, 308) | 2 | - |
| CPK, High (n=273, 262, 276) | 41 | - |
| Creatinine, High (n=294, 285, 303) | 16 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 32 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 25 | - |
| Eosinophils, High (n=265, 265, 284) | 22 | - |
| Eosinophils, Low (n=277, 268, 288) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 2 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 14 | - |
| GGT, High (n=234, 240, 245) | 24 | - |
| Hematocrit, High (n=280, 274, 290) | 6 | - |
| Hematocrit, Low (n=262, 251, 269) | 24 | - |
| Hemoglobin, High (n=282, 275, 294) | 3 | - |
| Hemoglobin, Low (n=265, 253, 269) | 28 | - |
| Leukocyte Count, High (n=277, 270, 292) | 9 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 7 | - |
| Lipase, High (n=255, 248, 269) | 132 | - |
| Lymphocytes, High (n=257, 262, 279) | 20 | - |
| Lymphocytes, Low (n=273, 266, 281) | 9 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 4 | - |
| MCV, High (n=267, 256, 273) | 25 | - |
| MCV, Low (n=270, 261, 286) | 3 | - |
| Monocytes, High (n=274, 267, 284) | 1 | - |
| Monocytes, Low (n=271, 264, 283) | 14 | - |
| Neutrophils, High (n=272, 263, 286) | 12 | - |
| Neutrophils, Low (n=271, 260, 280) | 6 | - |
| Platelet Count, High (n=273, 268, 287) | 3 | - |
| Platelet Count, Low (n=270, 260, 275) | 7 | - |
| Potassium, High (n=297, 291, 307) | 9 | - |
| Potassium, Low (n=298, 293, 308) | 8 | - |
| Sodium, High (n=291, 291, 307) | 10 | - |
| Sodium, Low (n=298, 292, 305) | 1 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 29 | - |
| UMCR, High (n=223, 212, 239) | 27 | - |
| SitagliptinAlkaline Phosphate, High (n=276, 258, 281) | 20 | - |
| ALT/SGPT, High (n=232, 237, 244) | 39 | - |
| Amylase Pancreatic, High (n=283, 277, 295) | 61 | - |
| Amylase Total, High (n=266, 265, 277) | 43 | - |
| AST/SGOT, High (n=273, 269, 284) | 36 | - |
| Basophils, High (n=276, 268, 288) | 1 | - |
| Basophils, Low (n=277, 268, 288) | 0 | - |
| Bilirubin Direct, High (n=295, 291, 307) | 3 | - |
| Bilirubin Total, High (n=295, 290, 305) | 6 | - |
| Calcitonin, High (n=233, 239, 235) | 4 | - |
| Chloride, High (n=299, 293, 310) | 1 | - |
| Chloride, Low (n=299, 293, 308) | 3 | - |
| CPK, High (n=273, 262, 276) | 54 | - |
| Creatinine, High (n=294, 285, 303) | 9 | - |
| Creatinine Clearance, High (n=164, 186, 180) | 34 | - |
| Creatinine Clearance, Low (n=292, 278, 303) | 20 | - |
| Eosinophils, High (n=265, 265, 284) | 14 | - |
| Eosinophils, Low (n=277, 268, 288) | 0 | - |
| Erythrocyte Count, High (n=283, 276, 292) | 1 | - |
| Erythrocyte Count, Low (n=278, 272, 285) | 19 | - |
| GGT, High (n=234, 240, 245) | 45 | - |
| Hematocrit, High (n=280, 274, 290) | 3 | - |
| Hematocrit, Low (n=262, 251, 269) | 29 | - |
| Hemoglobin, High (n=282, 275, 294) | 2 | - |
| Hemoglobin, Low (n=265, 253, 269) | 25 | - |
| Leukocyte Count, High (n=277, 270, 292) | 8 | - |
| Leukocyte Count, Low (n=277, 267, 284) | 14 | - |
| Lipase, High (n=255, 248, 269) | 126 | - |
| Lymphocytes, High (n=257, 262, 279) | 21 | - |
| Lymphocytes, Low (n=273, 266, 281) | 12 | - |
| MCHC, High (n=281, 274, 291) | 0 | - |
| MCHC, Low (n=280, 272, 290) | 5 | - |
| MCV, High (n=267, 256, 273) | 25 | - |
| MCV, Low (n=270, 261, 286) | 4 | - |
| Monocytes, High (n=274, 267, 284) | 11 | - |
| Monocytes, Low (n=271, 264, 283) | 17 | - |
| Neutrophils, High (n=272, 263, 286) | 13 | - |
| Neutrophils, Low (n=271, 260, 280) | 10 | - |
| Platelet Count, High (n=273, 268, 287) | 3 | - |
| Platelet Count, Low (n=270, 260, 275) | 8 | - |
| Potassium, High (n=297, 291, 307) | 8 | - |
| Potassium, Low (n=298, 293, 308) | 5 | - |
| Sodium, High (n=291, 291, 307) | 6 | - |
| Sodium, Low (n=298, 292, 305) | 5 | - |
| Urea Nitrogen, High (n=287, 282, 305) | 29 | - |
| UMCR, High (n=223, 212, 239) | 30 | - |
Number of Participants With Treatment-emergent Abnormal Lipid Tests
Time frame:Baseline through 26 and 104 weeks
threshold achievement, event
componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, Triglycerides, change
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 1.5 mg LY2189265Cholesterol, High, 26 Weeks (n=144, 158, 139, 58) | 16 | - |
| Cholesterol, High, 104 Weeks (n=151, 164, 146) | 34 | - |
| HDL-C, High, 26 Weeks (n=197, 201, 189, 78) | 1 | - |
| HDL-C, Low, 26 Weeks (n=127, 137, 129, 52) | 9 | - |
| HDL-C, High, 104 Weeks (n=206, 212, 199) | 2 | - |
| HDL-C, Low, 104 Weeks (n=134, 143, 138) | 13 | - |
| LDL-C, High, 26 Weeks (n=155, 163, 150, 61) | 15 | - |
| LDL-C, High, 104 Weeks (n=163, 170, 157) | 31 | - |
| TG, High, 26 Weeks (n=163, 174, 156, 64) | 6 | - |
| TG, High, 104 Weeks (n=170, 183, 166) | 13 | - |
| 0.75 mg LY2189265Cholesterol, High, 26 Weeks (n=144, 158, 139, 58) | 21 | - |
| Cholesterol, High, 104 Weeks (n=151, 164, 146) | 29 | - |
| HDL-C, High, 26 Weeks (n=197, 201, 189, 78) | 0 | - |
| HDL-C, Low, 26 Weeks (n=127, 137, 129, 52) | 13 | - |
| HDL-C, High, 104 Weeks (n=206, 212, 199) | 1 | - |
| HDL-C, Low, 104 Weeks (n=134, 143, 138) | 20 | - |
| LDL-C, High, 26 Weeks (n=155, 163, 150, 61) | 11 | - |
| LDL-C, High, 104 Weeks (n=163, 170, 157) | 23 | - |
| TG, High, 26 Weeks (n=163, 174, 156, 64) | 13 | - |
| TG, High, 104 Weeks (n=170, 183, 166) | 22 | - |
| SitagliptinCholesterol, High, 26 Weeks (n=144, 158, 139, 58) | 20 | - |
| Cholesterol, High, 104 Weeks (n=151, 164, 146) | 34 | - |
| HDL-C, High, 26 Weeks (n=197, 201, 189, 78) | 0 | - |
| HDL-C, Low, 26 Weeks (n=127, 137, 129, 52) | 8 | - |
| HDL-C, High, 104 Weeks (n=206, 212, 199) | 2 | - |
| HDL-C, Low, 104 Weeks (n=134, 143, 138) | 13 | - |
| LDL-C, High, 26 Weeks (n=155, 163, 150, 61) | 19 | - |
| LDL-C, High, 104 Weeks (n=163, 170, 157) | 29 | - |
| TG, High, 26 Weeks (n=163, 174, 156, 64) | 10 | - |
| TG, High, 104 Weeks (n=170, 183, 166) | 15 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)Cholesterol, High, 26 Weeks (n=144, 158, 139, 58) | 8 | - |
| Cholesterol, High, 104 Weeks (n=151, 164, 146) | NA | - |
| HDL-C, High, 26 Weeks (n=197, 201, 189, 78) | 0 | - |
| HDL-C, Low, 26 Weeks (n=127, 137, 129, 52) | 1 | - |
| HDL-C, High, 104 Weeks (n=206, 212, 199) | NA | - |
| HDL-C, Low, 104 Weeks (n=134, 143, 138) | NA | - |
| LDL-C, High, 26 Weeks (n=155, 163, 150, 61) | 7 | - |
| LDL-C, High, 104 Weeks (n=163, 170, 157) | NA | - |
| TG, High, 26 Weeks (n=163, 174, 156, 64) | 2 | - |
| TG, High, 104 Weeks (n=170, 183, 166) | NA | - |
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval
Time frame:Baseline, 26 weeks, 104 weeks
change from baseline, descriptive
componentsqtc f change, pr interval change
Posted result
| Group | Least-squares mean · milliseconds (msec) | 95% CI |
|---|---|---|
| 1.5 mg LY2189265PR Interval, 26 Weeks (n=256, 261, 268, 132) | 2.94 | - |
| PR Interval, 104 Weeks (n=168, 170, 167) | 4.59 | - |
| QTcF Interval, 26 Weeks (n=258, 262, 268, 132) | -3.86 | - |
| QTcF Interval, 104 Weeks (n=169, 170, 168) | -2.71 | - |
| 0.75 mg LY2189265PR Interval, 26 Weeks (n=256, 261, 268, 132) | 1.60 | - |
| PR Interval, 104 Weeks (n=168, 170, 167) | 3.06 | - |
| QTcF Interval, 26 Weeks (n=258, 262, 268, 132) | -2.44 | - |
| QTcF Interval, 104 Weeks (n=169, 170, 168) | -2.49 | - |
| SitagliptinPR Interval, 26 Weeks (n=256, 261, 268, 132) | 0.42 | - |
| PR Interval, 104 Weeks (n=168, 170, 167) | 3.19 | - |
| QTcF Interval, 26 Weeks (n=258, 262, 268, 132) | -1.31 | - |
| QTcF Interval, 104 Weeks (n=169, 170, 168) | -0.02 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks)PR Interval, 26 Weeks (n=256, 261, 268, 132) | 2.24 | - |
| PR Interval, 104 Weeks (n=168, 170, 167) | NA | - |
| QTcF Interval, 26 Weeks (n=258, 262, 268, 132) | 1.76 | - |
| QTcF Interval, 104 Weeks (n=169, 170, 168) | NA | - |
Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve
Time frame:Baseline through 52 weeks
AUC₀-∞
concentration, descriptive
Posted result
| Group | Mean · nanograms times hours per milliliter | 95% CI |
|---|---|---|
| 1.5 mg LY2189265 | 13378 | - |
| 0.75 mg LY2189265 | 7246 | - |
Antibodies to LY2189265
Time frame:Baseline through 104 weeks
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| LY2189265 | 9 | - |
Incidence of Hypoglycemic Episodes
Time frame:Baseline through 26 and 104 weeks
Documented hypoglycemia
event count, event
Rate of Hypoglycemic Episodes
Time frame:Baseline through 26 and 104 weeks
Documented hypoglycemia
event count, event
Number of Participants With Treatment-emergent Adverse Events at 26 Weeks
Time frame:Baseline through 26 weeks
Treatment-emergent AEs (any)
event count, event
Number of Participants With Treatment-emergent Adverse Events at 52 Weeks
Time frame:Baseline through 52 weeks
Treatment-emergent AEs (any)
event count, event
Number of Participants With Treatment-emergent Adverse Events at 104 Weeks
Time frame:Baseline through 104 weeks
Treatment-emergent AEs (any)
event count, event
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks
Time frame:Baseline through 26 weeks
event count, event
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks
Time frame:Baseline through 52 weeks
event count, event
Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks
Time frame:Baseline through 104 weeks
descriptive
Number of Participants With Treatment-emergent Abnormal Lipid Tests
Time frame:Baseline through 26 and 104 weeks
event count, event
Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval
Time frame:Baseline, 26 weeks, 104 weeks
change from baseline, descriptive
Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve
Time frame:Baseline through 52 weeks
AUC₀-∞
concentration, descriptive
Antibodies to LY2189265
Time frame:Baseline through 104 weeks
Immunogenicity (ADA)
threshold achievement, event
Number of Participants With Adjudicated Pancreatitis at 104 Weeks
Time frame:Baseline through 104 weeks
Pancreatitis
event count, event
Number of Participants With Adjudicated Pancreatitis at 104 Weeks
Time frame:Baseline through 104 weeks
Pancreatitis
event count, event
Posted result
| Group | Number · participants | 95% CI |
|---|---|---|
| 3.0 mg LY2189265 | 0 | - |
| 2.0 mg LY2189265 | 0 | - |
| 1.5 mg LY2189265 | 0 | - |
| 1.0 mg LY2189265 | 0 | - |
| 0.75 mg LY2189265 | 0 | - |
| 0.5 mg LY2189265 | 0 | - |
| 0.25 mg LY2189265 | 0 | - |
| Sitagliptin | 2 | - |
| Placebo/Sitagliptin (Baseline Through 26 Weeks) | 0 | - |
| Placebo/Sitagliptin (26 Weeks Through 104 Weeks) | 1 | - |
Publications (7)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Cardiovascular diabetology2023 Mar 9PMID36894938doi:10.1186/s12933-023-01775-xvia clinicaltrials gov reference derived + pubmed nct search
- Diabetic medicine : a journal of the British Diabetic Association2018 Mar (month)PMID28755389doi:10.1111/dme.13437via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2016 Aug (month)PMID27161178doi:10.1111/dom.12687via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2016 Apr (month)PMID26691396doi:10.1111/dom.12624via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2015 Sep (month)PMID25912221doi:10.1111/dom.12479via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2014 Aug (month)PMID24762094doi:10.1111/dom.12305via clinicaltrials gov reference derived + pubmed nct search
- Journal of diabetes science and technology2012 Nov 1PMID23294774doi:10.1177/193229681200600608via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.