GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2, PHASE3Results posted

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

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

1,202

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 7-9.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00734474

Org study ID11422

Secondary IDCTRI/2009/091/000969Clinical Trials Registry - India

Secondary IDH9X-MC-GBCFEli Lilly and Company

Timeline

Milestones

Study first posted2008-08-14estimated

Results first posted2015-01-28estimated

Last update posted2015-04-20estimated

Study start2008-08 (month precision)

Primary completion2011-06actual (month precision)

Study completion2012-07actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diabetes mellitus, type 2, for at least 6 months

•Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.

•Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of >8.0% to ≤9.5%

•Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m^2), inclusive

•Stable weight for 3 months prior to screening

•Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method

Exclusion criteria

•Diabetes mellitus, type 1

•Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin

•Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility

•Use of medications to promote weight loss

•Clinically-relevant cardiovascular event within 6 months prior to screening

•Poorly controlled hypertension

•Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease

•Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels >3.0 times the upper limit of normal

•Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance <60 milliliters per minute (mL/minute)

•Uncontrolled diabetes, defined as >2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.

•Uncontrolled endocrine or autoimmune abnormality

•History of a transplanted organ

•Chronic use of systemic glucocorticoid therapy

•Active or untreated malignancy

•Use of central nervous system (CNS) stimulants

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Cardiovascular outcomes

Patient-reported / QoL

Cardiovascular outcomes

4 endpoints

Secondary/registry result/low confidence

Resource Utilization

Time frame:Baseline through 52 and 104 weeks

event count, event

Posted result

Group	Value (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	—

Secondary/protocol endpoint/low confidence

Resource Utilization

Time frame:Baseline through 52 and 104 weeks

event count, descriptive

Other/protocol endpoint

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

Other_pre_specified/registry result

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	Value (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 endpoints

Secondary/registry result

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

Posted result

Group	Value (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	—

Secondary/registry result

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	Value (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	—

LS Mean Difference-1.7095% CI-2.27 – -1.14p<0.001ANCOVA

LS Mean Difference-1.1695% CI-1.73 – -0.60p<0.001ANCOVA

LS Mean Difference0.0295% CI-0.54 – 0.58p0.953ANCOVA

LS Mean Difference-1.5095% CI-2.08 – -0.92p<0.001ANCOVA

LS Mean Difference-1.0795% CI-1.65 – -0.48p<0.001ANCOVA

LS Mean Difference-1.1495% CI-1.78 – -0.49p<0.001ANCOVA

LS Mean Difference-0.6495% CI-1.29 – 0.01p0.054ANCOVA

Secondary/registry result

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	Value (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	—

Secondary/registry result

Waist Circumference Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (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	—

LS Mean Difference-1.6995% CI-2.45 – -0.93p<0.001Mixed Models Analysis

LS Mean Difference-0.5895% CI-1.34 – 0.18p0.133Mixed Models Analysis

LS Mean Difference-0.2595% CI-1.01 – 0.50p0.512Mixed Models Analysis

LS Mean Difference-1.4695% CI-2.23 – -0.69p<0.001Mixed Models Analysis

LS Mean Difference-0.5995% CI-1.36 – 0.17p0.128Mixed Models Analysis

LS Mean Difference-1.3695% CI-2.30 – -0.42p0.005Mixed Models Analysis

LS Mean Difference-0.5495% CI-1.48 – 0.40p0.256Mixed Models Analysis

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Body Weight Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Waist Circumference Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

16 endpoints

Primary/registry result

Glycosylated Hemoglobin (HbA1c) Change From Baseline

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
1.5 mg LY2189265	-1.10	—
0.75 mg LY2189265	-0.87	—
Sitagliptin	-0.39	—

LS Mean Difference-0.7195% CI-0.87 – -0.55p<0.001ANCOVA

LS Mean Difference-0.4795% CI-0.63 – -0.31p<0.001ANCOVA

LS Mean Difference-0.7195% CI-0.87 – -0.55p<0.001ANCOVA

Superiority analysis

LS Mean Difference-0.4795% CI-0.63 – -0.31p<0.001ANCOVA

Superiority analysis

Primary/protocol endpoint

Glycosylated Hemoglobin (HbA1c) Change From Baseline

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

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	Value (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	—

Secondary/registry result

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	Value (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	—

LS Mean Difference-1.2695% CI-1.42 – -1.09p<0.001ANCOVA

Superiority analysis

LS Mean Difference-1.0595% CI-1.21 – -0.88p<0.001ANCOVA

Superiority analysis

LS Mean Difference-0.6495% CI-0.81 – -0.48p<0.001ANCOVA

LS Mean Difference-0.6795% CI-0.84 – -0.50p<0.001ANCOVA

LS Mean Difference-0.3995% CI-0.56 – -0.22p<0.001ANCOVA

LS Mean Difference-0.6795% CI-0.84 – -0.50p<0.001ANCOVA

Superiority analysis

LS Mean Difference-0.3995% CI-0.56 – -0.22p<0.001ANCOVA

Superiority analysis

Secondary/registry result

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	Value (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	—

Secondary/registry result

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	Value (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	—

LS Mean Difference-1.8995% CI-2.27 – -1.51p<0.001Mixed Models Analysis

LS Mean Difference-1.4895% CI-1.85 – -1.10p<0.001Mixed Models Analysis

LS Mean Difference-0.4895% CI-0.86 – -0.11p0.012Mixed Models Analysis

LS Mean Difference-1.4795% CI-1.82 – -1.13p<0.001Mixed Models Analysis

LS Mean Difference-0.7395% CI-1.07 – -0.39p<0.001Mixed Models Analysis

LS Mean Difference-1.5195% CI-1.93 – -1.10p<0.001Mixed Models Analysis

LS Mean Difference-0.9295% CI-1.33 – -0.51p<0.001Mixed Models Analysis

Secondary/registry result

Fasting Insulin Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

change from baseline, improvement

Posted result

Group	Value (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	—

LS Mean Difference18.5195% CI-3.25 – 40.28p0.095Mixed Models Analysis

LS Mean Difference17.0895% CI-4.54 – 38.69p0.121Mixed Models Analysis

LS Mean Difference15.4195% CI-6.47 – 37.29p0.167Mixed Models Analysis

LS Mean Difference6.3895% CI-9.49 – 22.26p0.430Mixed Models Analysis

LS Mean Difference8.7795% CI-6.94 – 24.47p0.273Mixed Models Analysis

LS Mean Difference11.0795% CI-9.49 – 31.64p0.291Mixed Models Analysis

LS Mean Difference21.2895% CI1.03 – 41.53p0.039Mixed Models Analysis

Secondary/registry result

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	Value (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	—

Odds Ratio (OR)11.395% CI6.8 – 18.8p<0.001Regression, Logistic

Odds Ratio (OR)8.695% CI5.2 – 14.3p<0.001Regression, Logistic

Odds Ratio (OR)3.095% CI1.8 – 4.8p<0.001Regression, Logistic

Odds Ratio (OR)4.095% CI2.7 – 5.9p<0.001Regression, Logistic

Odds Ratio (OR)2.795% CI1.8 – 3.9p<0.001Regression, Logistic

Odds Ratio (OR)3.495% CI2.4 – 5.0p<0.001Regression, Logistic

Odds Ratio (OR)2.395% CI1.6 – 3.3p<0.001Regression, Logistic

Odds Ratio (OR)11.595% CI6.5 – 20.4p<0.001Regression, Logistic

Odds Ratio (OR)5.095% CI2.8 – 8.8p<0.001Regression, Logistic

Odds Ratio (OR)2.395% CI1.3 – 4.1p0.005Regression, Logistic

Odds Ratio (OR)4.495% CI2.9 – 6.8p<0.001Regression, Logistic

Odds Ratio (OR)2.395% CI1.5 – 3.5p<0.001Regression, Logistic

Odds Ratio (OR)5.295% CI3.4 – 7.9p<0.001Regression, Logistic

Odds Ratio (OR)2.495% CI1.5 – 3.7p<0.001Regression, Logistic

Secondary/registry result

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	Value (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	—

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Glycosylated Hemoglobin (HbA1c) Change From Baseline

Time frame:Baseline, 26 weeks, 104 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Fasting Blood Glucose Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting Insulin Change From Baseline

Time frame:Baseline, 26, 52, and 104 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints

Secondary/registry result

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

Posted result

Group	Value (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	—

Secondary/registry result

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	Value (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	—

Secondary/registry result

Change From Baseline in Pulse Rate

Time frame:Baseline, 26 weeks, 104 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (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	—

Secondary/registry result

Change From Baseline in Blood Pressure

Time frame:Baseline, 26 weeks, 104 weeks

change from baseline, improvement

Posted result

Group	Value (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	—

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change From Baseline in Blood Pressure at Dose Decision Point

Time frame:Baseline up to 27.4 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse Rate

Time frame:Baseline, 26 weeks, 104 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Baseline, 26 weeks, 104 weeks

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

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

Posted result

Group	Value (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	—

Secondary/registry result

Participant-reported Outcomes, EQ-5D

Time frame:Baseline, 52 weeks, and 104 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (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	—

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Participant-reported Outcomes, EQ-5D

Time frame:Baseline, 52 weeks, and 104 weeks

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

26 endpoints

Secondary/registry result

Incidence of Hypoglycemic Episodes

Time frame:Baseline through 26 and 104 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (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	—

Secondary/registry result

Rate of Hypoglycemic Episodes

Time frame:Baseline through 26 and 104 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (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	—

Secondary/registry result

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	Value (number), participants	95% CI
1.5 mg LY2189265	208	—
0.75 mg LY2189265	204	—
Sitagliptin	185	—
Placebo/Sitagliptin (Baseline Through 26 Weeks)	111	—

Secondary/registry result

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	Value (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	—

Secondary/registry result

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	Value (number), participants	95% CI
1.5 mg LY2189265	259	—
0.75 mg LY2189265	255	—
Sitagliptin	242	—

Secondary/registry result

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks

Time frame:Baseline through 26 weeks

event count, event

Posted result

Group	Value (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	—

Secondary/registry result

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks

Time frame:Baseline through 52 weeks

descriptive

Posted result

Group	Value (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	—

Secondary/registry result

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks

Time frame:Baseline through 104 weeks

descriptive

Posted result

Group	Value (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	—

Secondary/registry result

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	Value (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	—

Secondary/registry result/low confidence

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	Value (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	—

Secondary/registry result

Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve

Time frame:Baseline through 52 weeks

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanograms times hours per milliliter	95% CI
1.5 mg LY2189265	13378	—
0.75 mg LY2189265	7246	—

Secondary/registry result

Antibodies to LY2189265

Time frame:Baseline through 104 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
LY2189265	9	—

Secondary/protocol endpoint

Incidence of Hypoglycemic Episodes

Time frame:Baseline through 26 and 104 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Hypoglycemic Episodes

Time frame:Baseline through 26 and 104 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events at 26 Weeks

Time frame:Baseline through 26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events at 52 Weeks

Time frame:Baseline through 52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events at 104 Weeks

Time frame:Baseline through 104 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks

Time frame:Baseline through 26 weeks

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks

Time frame:Baseline through 52 weeks

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks

Time frame:Baseline through 104 weeks

descriptive

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Abnormal Lipid Tests

Time frame:Baseline through 26 and 104 weeks

event count, event

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve

Time frame:Baseline through 52 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Antibodies to LY2189265

Time frame:Baseline through 104 weeks

Immunogenicity (ADA)

threshold achievement, event

Other/protocol endpoint

Number of Participants With Adjudicated Pancreatitis at 104 Weeks

Time frame:Baseline through 104 weeks

Pancreatitis

event count, event

Other_pre_specified/registry result

Number of Participants With Adjudicated Pancreatitis at 104 Weeks

Time frame:Baseline through 104 weeks

Pancreatitis

event count, event

Posted result

Group	Value (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

Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Cardiovascular diabetology2023 Mar 9PMID36894938doi:10.1186/s12933-023-01775-xvia clinicaltrials gov reference derived + pubmed nct search
No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer.
Diabetic medicine : a journal of the British Diabetic Association2018 Mar (month)PMID28755389doi:10.1111/dme.13437via clinicaltrials gov reference derived + pubmed nct search
Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years.
Diabetes, obesity & metabolism2016 Aug (month)PMID27161178doi:10.1111/dom.12687via clinicaltrials gov reference derived + pubmed nct search
Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.
Diabetes, obesity & metabolism2016 Apr (month)PMID26691396doi:10.1111/dom.12624via clinicaltrials gov reference derived + pubmed nct search
Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study.
Diabetes, obesity & metabolism2015 Sep (month)PMID25912221doi:10.1111/dom.12479via clinicaltrials gov reference derived + pubmed nct search
Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5).
Diabetes, obesity & metabolism2014 Aug (month)PMID24762094doi:10.1111/dom.12305via clinicaltrials gov reference derived + pubmed nct search
Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.
Journal of diabetes science and technology2012 Nov 1PMID23294774doi:10.1177/193229681200600608via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 1, 2026 snapshot.