GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

807

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c ≥6.5%

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 IDNCT01126580

Org study ID11375

Secondary IDCTRI/2010/091/003036Clinical Trials Register India

Secondary IDH9X-MC-GBDCEli Lilly and Company

Timeline

Milestones

Study first posted2010-05-19estimated

Last update posted2015-01-16estimated

Results first posted2015-01-16estimated

Study start2010-05 (month precision)

Primary completion2011-11actual (month precision)

Study completion2012-06actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO] Classification of Diabetes).

•Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label.

•Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin.

•Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%.

•Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:

a)test negative for pregnancy at screening based on a serum pregnancy test, and

b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or

c)not be breastfeeding.

•Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening.

•Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2), inclusive.

•Are well-motivated, capable, and willing to:

a)perform self-monitored blood glucose (SMBG) testing;

b)learn how to self-inject treatment (LY2189265 or placebo) and

c)maintain a study diary.

Exclusion criteria

•Have type 1 diabetes mellitus.

•Are being or have been treated with any of the following medications:

a)chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable,

b)glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening,

c)drugs to cause weight loss within 3 months prior to screening,

d)thiazolidinediones (TZDs) within 3 months prior to screening,

e)chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or

f)illegal drugs.

•Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening.

•Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery.

•Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke.

•Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.

•Have a problem with the liver or pancreas.

•Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality.

•Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening.

•Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.

•Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.

•Have had an organ transplant except for corneal transplant.

•Have received treatment within the last 30 days with a drug which has not been regulatory approved.

•Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening.

•Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes.

•Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples.

•Have previously participated or signed an informed consent document for this same type of study and study drug.

Endpoints (60)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up

Time frame:Baseline through 52 weeks plus 30-day follow up

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265Any CV Event	1	—
Any Fatal CV Event	0	—
Any Nonfatal CV Event	1	—
0.75 mg LY2189265Any CV Event	2	—
Any Fatal CV Event	0	—
Any Nonfatal CV Event	2	—
MetforminAny CV Event	1	—
Any Fatal CV Event	0	—
Any Nonfatal CV Event	1	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up

Time frame:Baseline through 52 weeks plus 30-day follow up

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Non-fatal MI, Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Body Weight

Time frame:Baseline, 26 weeks, and 52 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 (n=267, 269, 267)	-2.29	—
52 weeks (n=267, 269, 267)	-1.93	—
0.75 mg LY218926526 weeks (n=267, 269, 267)	-1.36	—
52 weeks (n=267, 269, 267)	-1.09	—
Metformin26 weeks (n=267, 269, 267)	-2.22	—
52 weeks (n=267, 269, 267)	-2.20	—

p0.811ANCOVA

p0.003ANCOVA

p0.440ANCOVA

p0.001ANCOVA

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

Time frame:Baseline, 26 weeks, and 52 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per meter squared (kg/m^2)	95% CI
1.5 mg LY218926526 weeks	-0.86	—
52 weeks	-0.73	—
0.75 mg LY218926526 weeks	-0.51	—
52 weeks	-0.42	—
Metformin26 weeks	-0.82	—
52 weeks	-0.83	—

p0.750ANCOVA

p0.003ANCOVA

p0.412ANCOVA

p0.001ANCOVA

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Body Weight

Time frame:Baseline, 26 weeks, and 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

Time frame:Baseline, 26 weeks, and 52 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-0.78	—
0.75 mg LY2189265	-0.71	—
Metformin	-0.56	—

LS Mean Difference-0.2295% CI-0.36 – -0.08p<0.001ANCOVA

LS Mean Difference-0.1595% CI-0.29 – -0.01p<0.001ANCOVA

LS Mean Difference-0.2295% CI-0.36 – -0.08p0.002ANCOVA

Superiority analysis.

LS Mean Difference-0.1595% CI-0.29 – -0.01p0.020ANCOVA

Superiority analysis.

Primary/protocol endpoint

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-0.70	—
0.75 mg LY2189265	-0.55	—
Metformin	-0.51	—

LS Mean Difference-0.1995% CI-0.35 – -0.02p<0.001ANCOVA

LS Mean Difference-0.0495% CI-0.20 – 0.12p<0.001ANCOVA

LS Mean Difference-0.1995% CI-0.35 – -0.02p0.024ANCOVA

Superiority analysis.

LS Mean Difference-0.0495% CI-0.20 – 0.12p0.299ANCOVA

Superiority analysis.

Secondary/registry result

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

Time frame:26 weeks and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265HbA1c less than 7%, 26 weeks	61.5	—
HbA1c less than or equal to 6.5%, 26 weeks	46.0	—
HbA1c less than 7%, 52 weeks	60.0	—
HbA1c less than or equal to 6.5%, 52 weeks	42.3	—
0.75 mg LY2189265HbA1c less than 7%, 26 weeks	62.6	—
HbA1c less than or equal to 6.5%, 26 weeks	40.0	—
HbA1c less than 7%, 52 weeks	53.2	—
HbA1c less than or equal to 6.5%, 52 weeks	34.7	—
MetforminHbA1c less than 7%, 26 weeks	53.6	—
HbA1c less than or equal to 6.5%, 26 weeks	29.8	—
HbA1c less than 7%, 52 weeks	48.3	—
HbA1c less than or equal to 6.5%, 52 weeks	28.3	—

p0.023Regression, Logistic

p0.021Regression, Logistic

p<0.001Regression, Logistic

p0.011Regression, Logistic

p0.001Regression, Logistic

p0.269Regression, Logistic

p<0.001Regression, Logistic

p0.134Regression, Logistic

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

Time frame:Baseline, 26 weeks, and 52 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=244, 247, 245)	-1.61	—
52 weeks (n=207, 210, 194)	-1.56	—
0.75 mg LY218926526 weeks (n=244, 247, 245)	-1.46	—
52 weeks (n=207, 210, 194)	-1.00	—
Metformin26 weeks (n=244, 247, 245)	-1.34	—
52 weeks (n=207, 210, 194)	-1.15	—

p0.079Mixed Models Analysis

p0.451Mixed Models Analysis

p0.025Mixed Models Analysis

p0.402Mixed Models Analysis

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
1.5 mg LY218926526 weeks (n=195, 200, 211)	-1.98	—
52 weeks (n=197, 200, 212)	-1.99	—
0.75 mg LY218926526 weeks (n=195, 200, 211)	-1.75	—
52 weeks (n=197, 200, 212)	-1.71	—
Metformin26 weeks (n=195, 200, 211)	-1.68	—
52 weeks (n=197, 200, 212)	-1.58	—

p0.061ANCOVA

p0.647ANCOVA

p0.022ANCOVA

p0.469ANCOVA

Secondary/registry result/low confidence

Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA2	95% CI
1.5 mg LY2189265HOMA2-%B, 26 weeks (n=207, 207, 215)	36.55	—
HOMA2-%B, 52 weeks (n=179, 185, 170)	29.97	—
HOMA2-%S, 26 weeks (n=207, 207, 215)	0.95	—
HOMA2-%S, 52 weeks (n=179, 185, 170)	5.29	—
0.75 mg LY2189265HOMA2-%B, 26 weeks (n=207, 207, 215)	28.96	—
HOMA2-%B, 52 weeks (n=179, 185, 170)	22.5	—
HOMA2-%S, 26 weeks (n=207, 207, 215)	2.71	—
HOMA2-%S, 52 weeks (n=179, 185, 170)	1.84	—
MetforminHOMA2-%B, 26 weeks (n=207, 207, 215)	14.11	—
HOMA2-%B, 52 weeks (n=179, 185, 170)	9.77	—
HOMA2-%S, 26 weeks (n=207, 207, 215)	9.99	—
HOMA2-%S, 52 weeks (n=179, 185, 170)	10.83	—

p<0.001Mixed Models Analysis

p0.003Mixed Models Analysis

p0.001Mixed Models Analysis

p0.010Mixed Models Analysis

p0.077Mixed Models Analysis

p0.004Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

Time frame:26 weeks and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

Time frame:Baseline, 26 weeks, and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 26 weeks, and 52 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

Time frame:Baseline, 26 weeks, and 52 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg LY218926526 weeks (n=230, 237, 221)	1.60	—
52 weeks (n=212, 212, 205)	2.02	—
0.75 mg LY218926526 weeks (n=230, 237, 221)	2.57	—
52 weeks (n=212, 212, 205)	2.36	—
Metformin26 weeks (n=230, 237, 221)	0.82	—
52 weeks (n=212, 212, 205)	1.27	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Pulse Rate

Time frame:Baseline, 26 weeks, and 52 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg LY218926526 weeks (n=244, 251, 239)	2.39	—
52 weeks (n=221, 219, 215)	1.84	—
0.75 mg LY218926526 weeks (n=244, 251, 239)	2.14	—
52 weeks (n=221, 219, 215)	1.63	—
Metformin26 weeks (n=244, 251, 239)	1.59	—
52 weeks (n=221, 219, 215)	1.12	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Blood Pressure

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliliters of mercury (mmHg)	95% CI
1.5 mg LY2189265SBP, 26 weeks (n=244, 251, 239)	-1.89	—
SBP, 52 weeks (n=221, 219, 215)	-0.11	—
DBP, 26 weeks (n=244, 251, 239)	0.05	—
DBP, 52 weeks (n=221, 219, 215)	0.31	—
0.75 mg LY2189265SBP, 26 weeks (n=244, 251, 239)	-2.61	—
SBP, 52 weeks (n=221, 219, 215)	-2.74	—
DBP, 26 weeks (n=244, 251, 239)	-1.02	—
DBP, 52 weeks (n=221, 219, 215)	-1.37	—
MetforminSBP, 26 weeks (n=244, 251, 239)	-0.91	—
SBP, 52 weeks (n=221, 219, 215)	-0.98	—
DBP, 26 weeks (n=244, 251, 239)	-0.64	—
DBP, 52 weeks (n=221, 219, 215)	-0.38	—

Secondary/registry result

Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

Time frame:Baseline, 26 weeks, and 52 weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (median), percentage change in total cholesterol	95% CI
1.5 mg LY218926526 weeks (n=244, 244, 243)	-3.86	-10.83 – 5.24
52 weeks (n=247, 248, 245)	-1.69	-11.11 – 7.45
0.75 mg LY218926526 weeks (n=244, 244, 243)	-1.77	-9.78 – 7.57
52 weeks (n=247, 248, 245)	-0.78	-10.02 – 8.10
Metformin26 weeks (n=244, 244, 243)	-3.51	-12.19 – 5.45
52 weeks (n=247, 248, 245)	-3.88	-12.14 – 5.69

Secondary/registry result

Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline, 26 weeks, and 52 weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (median), percentage change in HDL-C	95% CI
1.5 mg LY218926526 weeks (n=246, 244, 244)	2.39	-4.11 – 13.54
52 weeks (n=248, 248, 246)	4.95	-4.55 – 13.17
0.75 mg LY218926526 weeks (n=246, 244, 244)	4.20	-5.66 – 14.66
52 weeks (n=248, 248, 246)	2.31	-5.16 – 12.56
Metformin26 weeks (n=246, 244, 244)	5.78	-2.66 – 14.13
52 weeks (n=248, 248, 246)	4.32	-6.56 – 13.64

Secondary/registry result

Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline, 26 weeks, and 52 weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (median), percentage change in LDL-C	95% CI
1.5 mg LY218926526 weeks (n=233, 231, 221)	-6.86	-18.26 – 8.20
52 weeks (n=236, 240, 231)	-2.06	-15.93 – 9.31
0.75 mg LY218926526 weeks (n=233, 231, 221)	-2.70	-15.33 – 9.15
52 weeks (n=236, 240, 231)	-2.34	-15.22 – 10.56
Metformin26 weeks (n=233, 231, 221)	-8.97	-20.21 – 5.00
52 weeks (n=236, 240, 231)	-7.23	-18.56 – 4.36

Secondary/registry result

Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides

Time frame:Baseline, 26 weeks, and 52 weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (median), percentage change in triglycerides	95% CI
1.5 mg LY218926526 weeks (n=252, 252, 253)	-2.35	-22.32 – 13.61
52 weeks (n=255, 256, 254)	-4.27	-22.91 – 19.23
0.75 mg LY218926526 weeks (n=252, 252, 253)	-1.96	-21.66 – 22.63
52 weeks (n=255, 256, 254)	-0.86	-22.31 – 25.37
Metformin26 weeks (n=252, 252, 253)	2.56	-16.00 – 23.79
52 weeks (n=255, 256, 254)	1.91	-21.65 – 24.04

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

Time frame:Baseline, 26 weeks, and 52 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Pulse Rate

Time frame:Baseline, 26 weeks, and 52 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Blood Pressure

Time frame:Baseline, 26 weeks, and 52 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

Time frame:Baseline, 26 weeks, and 52 weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline, 26 weeks, and 52 weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline, 26 weeks, and 52 weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides

Time frame:Baseline, 26 weeks, and 52 weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

10 endpoints

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY218926526 weeks (n=247, 251, 247)	0.09	—
52 weeks (n=247, 252, 248)	0.39	—
0.75 mg LY218926526 weeks (n=247, 251, 247)	0.19	—
52 weeks (n=247, 252, 248)	-0.05	—
Metformin26 weeks (n=247, 251, 247)	0.02	—
52 weeks (n=247, 252, 248)	0.28	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

Time frame:Baseline, 26 weeks, and 52 weeks

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY218926526 weeks (n=248, 254, 249)	0.72	—
52 weeks (n=249, 255, 250)	0.45	—
0.75 mg LY218926526 weeks (n=248, 254, 249)	0.63	—
52 weeks (n=249, 255, 250)	0.61	—
Metformin26 weeks (n=248, 254, 249)	0.79	—
52 weeks (n=249, 255, 250)	0.75	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY218926526 weeks (n=244, 249, 241)	1.93	—
52 weeks (n=245, 251, 244)	1.82	—
0.75 mg LY218926526 weeks (n=244, 249, 241)	1.81	—
52 weeks (n=245, 251, 244)	1.29	—
Metformin26 weeks (n=244, 249, 241)	2.04	—
52 weeks (n=245, 251, 244)	1.94	—

Secondary/registry result

Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

Time frame:52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	12.92	—
0.75 mg LY2189265	12.73	—
Metformin	12.58	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY218926526 weeks (n=245, 253, 248)	0.24	—
52 weeks (n=247, 255, 249)	0.49	—
0.75 mg LY218926526 weeks (n=245, 253, 248)	-0.16	—
52 weeks (n=247, 255, 249)	0.42	—
Metformin26 weeks (n=245, 253, 248)	0.41	—
52 weeks (n=247, 255, 249)	0.59	—

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

Time frame:Baseline, 26 weeks, and 52 weeks

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Safety / tolerability / PK

18 endpoints

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

Time frame:26 weeks and 52 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY218926526 weeks	163	—
52 weeks	179	—
0.75 mg LY218926526 weeks	150	—
52 weeks	177	—
Metformin26 weeks	151	—
52 weeks	170	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, descriptive

componentsqtc interval change fridericia, pr interval change

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
1.5 mg LY2189265QTcF interval, 26 weeks (n=230, 237, 221)	2.60	—
QTcF interval, 52 weeks (n=212, 212, 205)	3.76	—
PR interval, 26 weeks (n=226, 235, 218)	-0.04	—
PR interval, 52 weeks (n=209, 210, 201)	1.15	—
0.75 mg LY2189265QTcF interval, 26 weeks (n=230, 237, 221)	1.38	—
QTcF interval, 52 weeks (n=212, 212, 205)	0.73	—
PR interval, 26 weeks (n=226, 235, 218)	-0.01	—
PR interval, 52 weeks (n=209, 210, 201)	1.53	—
MetforminQTcF interval, 26 weeks (n=230, 237, 221)	-0.91	—
QTcF interval, 52 weeks (n=212, 212, 205)	-0.53	—
PR interval, 26 weeks (n=226, 235, 218)	-2.04	—
PR interval, 52 weeks (n=209, 210, 201)	-2.88	—

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units per liter (U/L)	95% CI
1.5 mg LY2189265Amylase (total), 26 weeks	7.00	2.00 – 13.00
Amylase (total), 52 weeks	5.50	-1.00 – 13.00
Amylase (PD), 26 weeks	5.00	2.00 – 9.00
Amylase (PD), 52 weeks	4.00	1.00 – 7.00
Lipase, 26 weeks	7.00	1.00 – 16.00
Lipase, 52 weeks	5.00	-1.00 – 13.00
0.75 mg LY2189265Amylase (total), 26 weeks	6.00	0.00 – 13.00
Amylase (total), 52 weeks	5.00	-1.00 – 13.00
Amylase (PD), 26 weeks	4.00	1.00 – 7.00
Amylase (PD), 52 weeks	3.00	0.00 – 8.00
Lipase, 26 weeks	5.00	0.00 – 13.00
Lipase, 52 weeks	5.00	0.00 – 12.00
MetforminAmylase (total), 26 weeks	4.00	-2.00 – 10.00
Amylase (total), 52 weeks	4.00	-2.00 – 9.00
Amylase (PD), 26 weeks	1.00	-1.00 – 5.00
Amylase (PD), 52 weeks	2.00	-1.00 – 5.00
Lipase, 26 weeks	1.00	-4.00 – 8.00
Lipase, 52 weeks	1.00	-4.00 – 6.00

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

Time frame:Baseline, 26 weeks, and 52 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (median), picograms per milliliter (pcg/mL)	95% CI
1.5 mg LY218926526 weeks	0.00	0.00 – 0.00
52 weeks	0.00	0.00 – 0.00
0.75 mg LY218926526 weeks	0.00	0.00 – 0.00
52 weeks	0.00	0.00 – 0.00
Metformin26 weeks	0.00	0.00 – 0.00
52 weeks	0.00	0.00 – 0.00

Secondary/registry result

Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies

Time frame:Baseline through 52 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg or 0.75 mg LY2189265	10	—

Secondary/registry result

Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks

Time frame:Baseline through 26 weeks and 52 weeks

event count, event

Posted result

Group	Value (number), events	95% CI
1.5 mg LY2189265Severe, 26 weeks (n=241, 248, 236)	0	—
Severe, 52 weeks (n=214, 217, 199)	0	—
Documented Symptomatic, 26 weeks (n=241, 248, 236)	2	—
Documented Symptomatic, 52 weeks (n=214, 217, 199)	7	—
Asymptomatic, 26 weeks (n=241, 248, 236)	19	—
Asymptomatic, 52 weeks (n=214, 217, 199)	5	—
0.75 mg LY2189265Severe, 26 weeks (n=241, 248, 236)	0	—
Severe, 52 weeks (n=214, 217, 199)	0	—
Documented Symptomatic, 26 weeks (n=241, 248, 236)	6	—
Documented Symptomatic, 52 weeks (n=214, 217, 199)	8	—
Asymptomatic, 26 weeks (n=241, 248, 236)	9	—
Asymptomatic, 52 weeks (n=214, 217, 199)	9	—
MetforminSevere, 26 weeks (n=241, 248, 236)	0	—
Severe, 52 weeks (n=214, 217, 199)	0	—
Documented Symptomatic, 26 weeks (n=241, 248, 236)	2	—
Documented Symptomatic, 52 weeks (n=214, 217, 199)	2	—
Asymptomatic, 26 weeks (n=241, 248, 236)	13	—
Asymptomatic, 52 weeks (n=214, 217, 199)	9	—

Secondary/registry result

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per year	95% CI
1.5 mg LY2189265Severe	0.00	—
Documented Symptomatic	0.62	—
Asymptomatic	0.24	—
0.75 mg LY2189265Severe	0.00	—
Documented Symptomatic	0.15	—
Asymptomatic	0.30	—
MetforminSevere	0.00	—
Documented Symptomatic	0.09	—
Asymptomatic	0.18	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up

Time frame:Baseline through 52 weeks plus 30-day follow up

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	0	—
0.75 mg LY2189265	0	—
Metformin	0	—

Secondary/registry result

Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)

Time frame:4 weeks, 13 weeks, 26 weeks, and 52 weeks

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogram hours per milliliter (ng*hr/mL)	95% CI
1.5 mg LY2189265	12036	—
0.75 mg LY2189265	5919	—

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

Time frame:26 weeks and 52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

Time frame:Baseline, 26 weeks, and 52 weeks

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies

Time frame:Baseline through 52 weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks

Time frame:Baseline through 26 weeks and 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up

Time frame:Baseline through 52 weeks plus 30-day follow up

Pancreatitis

event count, event

Secondary/protocol endpoint

Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)

Time frame:4 weeks, 13 weeks, 26 weeks, and 52 weeks

AUC₀–∞

concentration, descriptive

Publications (4)

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

Metformin monotherapy for adults with type 2 diabetes mellitus.
The Cochrane database of systematic reviews2020 Jun 5PMID32501595doi:10.1002/14651858.CD012906.pub2via 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
Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).
Diabetes care2014 Aug (month)PMID24842985doi:10.2337/dc13-2759via 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.