AWARD-2

CompletedPhase 3Results posted

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

A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

810

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c ≥7%

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 IDNCT01075282

Org study ID11374

Secondary IDH9X-MC-GBDBEli Lilly and Company

Timeline

Milestones

Study first posted2010-02-25estimated

Last update posted2015-01-16estimated

Results first posted2015-01-16estimated

Study start2010-02 (month precision)

Primary completion2012-05actual (month precision)

Study completion2012-11actual (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

•Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)

1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication

2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications

•Accept treatment with metformin and glimepiride throughout the study, as per protocol

•Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.

•Stable weight for 3 months prior to screening

•Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

•Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion criteria

•Type 1 Diabetes

•HbA1c equal to or less than 6.5 at randomization

•Chronic insulin use

•Taking drugs to promote weight loss by prescription or over the counter

•Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled

•History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening

•Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility

•Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit

•Acute or chronic pancreatitis of any form

•Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)

•History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer

•A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening

•Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

•History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years

•Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing

•Organ transplant except cornea

•Have enrolled in another clinical trial within the last 30 days

•Have previously signed an informed consent or participated in a LY2189265 study

•Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Endpoints (52)

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

Patient-reported / QoL

Cardiometabolic biomarkers

Weight & body composition

Cardiovascular outcomes

Other (unclassified)

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 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
LY2189265 1.5 mgAny CV event, 26 weeks	2	—
Any fatal CV event, 26 weeks	0	—
Any non-fatal CV event, 26 weeks	2	—
Any CV event, 52 weeks	3	—
Any fatal CV event, 52 weeks	0	—
Any non-fatal CV event, 52 weeks	3	—
Any CV event, 78 week	3	—
Any fatal CV event, 78 week	0	—
Any non-fatal CV event, 78 week	3	—
LY2189265 0.75 mgAny CV event, 26 weeks	1	—
Any fatal CV event, 26 weeks	0	—
Any non-fatal CV event, 26 weeks	1	—
Any CV event, 52 weeks	4	—
Any fatal CV event, 52 weeks	0	—
Any non-fatal CV event, 52 weeks	4	—
Any CV event, 78 week	6	—
Any fatal CV event, 78 week	1	—
Any non-fatal CV event, 78 week	6	—
Insulin GlargineAny CV event, 26 weeks	3	—
Any fatal CV event, 26 weeks	0	—
Any non-fatal CV event, 26 weeks	3	—
Any CV event, 52 weeks	6	—
Any fatal CV event, 52 weeks	1	—
Any non-fatal CV event, 52 weeks	5	—
Any CV event, 78 week	9	—
Any fatal CV event, 78 week	1	—
Any non-fatal CV event, 78 week	8	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Expanded / custom MACE composite

event count, event

componentsCardiovascular death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks for Body Weight

Time frame:Baseline, 26, 52, and 78 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
LY2189265 1.5 mg26 weeks	-1.82	—
52 weeks	-1.87	—
78 weeks	-1.96	—
LY2189265 0.75 mg26 weeks	-1.47	—
52 weeks	-1.33	—
78 weeks	-1.54	—
Insulin Glargine26 weeks	1.01	—
52 weeks	1.44	—
78 weeks	1.28	—

LS Mean Difference2.8395% CI2.33 – 3.33p<0.001ANCOVA

LS Mean Difference2.4895% CI1.99 – 2.99p<0.001ANCOVA

LS Mean Difference3.3195% CI2.71 – 3.90p<0.001ANCOVA

LS Mean Difference2.7795% CI2.17 – 3.36p<0.001ANCOVA

LS Mean Difference3.2495% CI2.59 – 3.89p<0.001ANCOVA

LS Mean Difference2.8295% CI2.17 – 3.46p<0.001ANCOVA

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index

Time frame:Baseline, 26, 52, and 78 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per square meter (kg/m^2)	95% CI
LY2189265 1.5 mg26 weeks (n=257, 261, 245)	-0.64	—
52 weeks (n=250, 252, 238)	-0.64	—
78 weeks (n=246, 244, 238)	-0.64	—
LY2189265 0.75 mg26 weeks (n=257, 261, 245)	-0.50	—
52 weeks (n=250, 252, 238)	-0.39	—
78 weeks (n=246, 244, 238)	-0.39	—
Insulin Glargine26 weeks (n=257, 261, 245)	0.44	—
52 weeks (n=250, 252, 238)	0.62	—
78 weeks (n=246, 244, 238)	0.59	—

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks for Body Weight

Time frame:Baseline, 26, 52, and 78 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index

Time frame:Baseline, 26, 52, and 78 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Change From Baseline to 52 Weeks 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
LY2189265 1.5 mg	-1.08	—
LY2189265 0.75 mg	-0.76	—
Insulin Glargine	-0.63	—

LS Mean Difference-0.4595% CI-0.60 – -0.29p<0.001ANCOVA

LS Mean Difference-0.1395% CI-0.29 – 0.02p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.4595% CI-0.60 – -0.29p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.1395% CI-0.29 – 0.02p0.05ANCOVA

Superiority analysis.

Primary/protocol endpoint

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

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks, and 78 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent	95% CI
LY2189265 1.5 mg26 weeks (n=263, 266, 258)	-1.16	—
78 weeks (n=263, 267, 259)	-0.90	—
LY2189265 0.75 mg26 weeks (n=263, 266, 258)	-0.89	—
78 weeks (n=263, 267, 259)	-0.62	—
Insulin Glargine26 weeks (n=263, 266, 258)	-0.65	—
78 weeks (n=263, 267, 259)	-0.59	—

LS Mean Difference-0.5195% CI-0.65 – -0.37p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.2495% CI-0.38 – -0.10p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.5195% CI-0.65 – -0.37p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.2495% CI-0.38 – -0.10p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.3195% CI-0.50 – -0.13p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.0395% CI-0.21 – 0.15p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.3195% CI-0.50 – -0.13p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.0395% CI-0.21 – 0.15p0.378ANCOVA

Superiority analysis.

Secondary/registry result

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg26 weeks (n=263, 266, 258)	153	—
52 weeks (n=263, 267, 259)	140	—
78 weeks (n=263, 267, 259)	129	—
LY2189265 0.75 mg26 weeks (n=263, 266, 258)	122	—
52 weeks (n=263, 267, 259)	99	—
78 weeks (n=263, 267, 259)	91	—
Insulin Glargine26 weeks (n=263, 266, 258)	84	—
52 weeks (n=263, 267, 259)	80	—
78 weeks (n=263, 267, 259)	79	—

Odds Ratio (OR)4.6195% CI2.98 – 7.11p<0.001Regression, Logistic

Odds Ratio (OR)2.1395% CI1.41 – 3.24p<0.001Regression, Logistic

Odds Ratio (OR)3.7695% CI2.45 – 5.75p<0.001Regression, Logistic

Odds Ratio (OR)1.4295% CI0.94 – 2.15p0.098Regression, Logistic

Odds Ratio (OR)2.7795% CI1.85 – 4.14p<0.001Regression, Logistic

Odds Ratio (OR)1.2295% CI0.82 – 1.82p0.334Regression, Logistic

Secondary/registry result

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg26 weeks (n=263, 266, 258)	97	—
52 weeks (n=263, 267, 259)	71	—
78 weeks (n=263, 267, 259)	74	—
LY2189265 0.75 mg26 weeks (n=263, 266, 258)	74	—
52 weeks (n=263, 267, 259)	60	—
78 weeks (n=263, 267, 259)	59	—
Insulin Glargine26 weeks (n=263, 266, 258)	40	—
52 weeks (n=263, 267, 259)	35	—
78 weeks (n=263, 267, 259)	43	—

Odds Ratio (OR)4.7095% CI2.90 – 7.63p<0.001Regression, Logistic

Odds Ratio (OR)2.5495% CI1.57 – 4.11p<0.001Regression, Logistic

Odds Ratio (OR)2.9795% CI1.81 – 4.85p<0.001Regression, Logistic

Odds Ratio (OR)2.0795% CI1.26 – 3.39p0.004Regression, Logistic

Odds Ratio (OR)2.2795% CI1.44 – 3.57p<0.001Regression, Logistic

Odds Ratio (OR)1.5395% CI0.96 – 2.42p0.073Regression, Logistic

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
LY2189265 1.5 mg26 weeks (n=199, 204, 190)	-1.79	—
52 weeks (n=180, 185, 176)	-1.69	—
78 weeks (n=172, 164, 168)	-1.55	—
LY2189265 0.75 mg26 weeks (n=199, 204, 190)	-1.46	—
52 weeks (n=180, 185, 176)	-1.32	—
78 weeks (n=172, 164, 168)	-1.15	—
Insulin Glargine26 weeks (n=199, 204, 190)	-1.58	—
52 weeks (n=180, 185, 176)	-1.44	—
78 weeks (n=172, 164, 168)	-1.47	—

p0.109Mixed Models Analysis

p0.335Mixed Models Analysis

p0.091Mixed Models Analysis

p0.400Mixed Models Analysis

p0.641Mixed Models Analysis

p0.055Mixed Models Analysis

Secondary/registry result/low confidence

Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 52, and 78 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity), C-peptide AUC

Posted result

Group	Value (least_squares_mean), percentage of HOMA2	95% CI
LY2189265 1.5 mgHOMA2-%B, 52 weeks (n=175, 181)	29.95	—
HOMA2-%B, 78 weeks (n=167, 165)	28.54	—
HOMA2-%S, 52 weeks (n=175,181)	-2.89	—
HOMA2-%S, 78 weeks (n=167, 165)	-2.64	—
LY2189265 0.75 mgHOMA2-%B, 52 weeks (n=175, 181)	24.60	—
HOMA2-%B, 78 weeks (n=167, 165)	15.66	—
HOMA2-%S, 52 weeks (n=175,181)	-2.66	—
HOMA2-%S, 78 weeks (n=167, 165)	-3.62	—

Secondary/registry result

Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

event count, event

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg26 weeks	2	—
52 weeks	11	—
78 weeks	24	—
LY2189265 0.75 mg26 weeks	4	—
52 weeks	20	—
78 weeks	34	—
Insulin Glargine26 weeks	0	—
52 weeks	8	—
78 weeks	16	—

Secondary/protocol endpoint

Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks, and 78 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 52, and 78 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity)

Secondary/protocol endpoint

Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

event count, event

Cardiometabolic biomarkers

7 endpoints

Secondary/registry result

Change From Baseline to 52 and 78 Weeks in Glucagon Concentration

Time frame:Baseline, 52, and 78 weeks

glucagon concentration

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomoles per liter (pmol/L)	95% CI
LY2189265 1.5 mg52 weeks (n=232, 231, 228)	-3.91	—
78 weeks (n=235, 235, 232)	-3.57	—
LY2189265 0.75 mg52 weeks (n=232, 231, 228)	-3.31	—
78 weeks (n=235, 235, 232)	-3.37	—
Insulin Glargine52 weeks (n=232, 231, 228)	-3.85	—
78 weeks (n=235, 235, 232)	-3.65	—

Secondary/registry result

Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate

Time frame:Baseline, 26, 52, and 78 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
LY2189265 1.5 mg26 weeks (n=257, 260, 245)	1.56	—
52 weeks (n=250, 252, 240)	1.29	—
78 weeks (n=246, 244, 238)	1.31	—
LY2189265 0.75 mg26 weeks (n=257, 260, 245)	0.74	—
52 weeks (n=250, 252, 240)	0.51	—
78 weeks (n=246, 244, 238)	0.61	—
Insulin Glargine26 weeks (n=257, 260, 245)	-1.21	—
52 weeks (n=250, 252, 240)	-0.52	—
78 weeks (n=246, 244, 238)	-0.91	—

Secondary/registry result

Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliliter of mercury (mmHG)	95% CI
LY2189265 1.5 mgSBP, 26 weeks (n=257, 261, 245)	-1.28	—
SBP, 52 weeks (n=250, 252, 240)	0.17	—
SBP, 78 weeks (n=246, 244, 238)	-0.70	—
DBP, 26 weeks (n=257, 261, 245)	-0.16	—
DBP, 52 weeks (n=250, 252, 240)	-0.26	—
DBP, 78 weeks (n=246, 244, 238)	-0.44	—
LY2189265 0.75 mgSBP, 26 weeks (n=257, 261, 245)	-1.60	—
SBP, 52 weeks (n=250, 252, 240)	0.09	—
SBP, 78 weeks (n=246, 244, 238)	-0.59	—
DBP, 26 weeks (n=257, 261, 245)	-0.17	—
DBP, 52 weeks (n=250, 252, 240)	-0.19	—
DBP, 78 weeks (n=246, 244, 238)	-0.36	—
Insulin GlargineSBP, 26 weeks (n=257, 261, 245)	-0.03	—
SBP, 52 weeks (n=250, 252, 240)	0.51	—
SBP, 78 weeks (n=246, 244, 238)	0.51	—
DBP, 26 weeks (n=257, 261, 245)	-0.29	—
DBP, 52 weeks (n=250, 252, 240)	-0.93	—
DBP, 78 weeks (n=246, 244, 238)	-1.04	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate

Time frame:Baseline, 26, 52, and 78 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
LY2189265 1.5 mg26 weeks (n=241, 247, 231)	2.64	—
52 weeks (n=232, 242, 231)	2.41	—
78 weeks (n=223, 222, 225)	2.49	—
LY2189265 0.75 mg26 weeks (n=241, 247, 231)	0.90	—
52 weeks (n=232, 242, 231)	0.38	—
78 weeks (n=223, 222, 225)	0.47	—
Insulin Glargine26 weeks (n=241, 247, 231)	-1.24	—
52 weeks (n=232, 242, 231)	-1.01	—
78 weeks (n=223, 222, 225)	-0.26	—

Secondary/protocol endpoint

Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate

Time frame:Baseline, 26, 52, and 78 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate

Time frame:Baseline, 26, 52, and 78 weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

8 endpoints

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension

Time frame:Baseline, 26, 52, and 78 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
LY2189265 1.5 mgEQ-5D UK, 26 weeks (n=257, 254, 249)	0.01	—
EQ-5D UK, 52 weeks (n=259, 260, 253)	0.01	—
EQ-5D UK, 78 weeks (n=259, 260, 253)	0.01	—
VAS, 26 weeks (n=253, 252, 243)	3.3	—
VAS, 52 weeks (n=260, 258, 252)	3.2	—
VAS, 78 weeks (n=260, 258, 252)	3.8	—
LY2189265 0.75 mgEQ-5D UK, 26 weeks (n=257, 254, 249)	0.00	—
EQ-5D UK, 52 weeks (n=259, 260, 253)	0.00	—
EQ-5D UK, 78 weeks (n=259, 260, 253)	0.00	—
VAS, 26 weeks (n=253, 252, 243)	3.4	—
VAS, 52 weeks (n=260, 258, 252)	2.3	—
VAS, 78 weeks (n=260, 258, 252)	3.2	—
Insulin GlargineEQ-5D UK, 26 weeks (n=257, 254, 249)	-0.01	—
EQ-5D UK, 52 weeks (n=259, 260, 253)	-0.04	—
EQ-5D UK, 78 weeks (n=259, 260, 253)	0.00	—
VAS, 26 weeks (n=253, 252, 243)	0.8	—
VAS, 52 weeks (n=260, 258, 252)	1.1	—
VAS, 78 weeks (n=260, 258, 252)	2.2	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
LY2189265 1.5 mg26 weeks (n=256, 256, 248)	0.7	—
52 weeks (n=260, 261, 249)	0.9	—
78 weeks (n=260, 261, 249)	1.0	—
LY2189265 0.75 mg26 weeks (n=256, 256, 248)	0.1	—
52 weeks (n=260, 261, 249)	0.4	—
78 weeks (n=260, 261, 249)	0.3	—
Insulin Glargine26 weeks (n=256, 256, 248)	-0.3	—
52 weeks (n=260, 261, 249)	-0.6	—
78 weeks (n=260, 261, 249)	-0.3	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
LY2189265 1.5 mg26 weeks (n=258, 258, 251)	0.1	—
52 weeks (n=260, 261, 252)	0.5	—
78 weeks (n=260, 261, 252)	0.5	—
LY2189265 0.75 mg26 weeks (n=258, 258, 251)	0.2	—
52 weeks (n=260, 261, 252)	0.2	—
78 weeks (n=260, 261, 252)	0.3	—
Insulin Glargine26 weeks (n=258, 258, 251)	-0.1	—
52 weeks (n=260, 261, 252)	0.1	—
78 weeks (n=260, 261, 252)	0.1	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
LY2189265 1.5 mg26 weeks (n=255, 255, 244)	-2.8	—
52 weeks (n=258, 259, 245)	-4.2	—
78 weeks (n=258, 259, 245)	-4.6	—
LY2189265 0.75 mg26 weeks (n=255, 255, 244)	-2.4	—
52 weeks (n=258, 259, 245)	-4.1	—
78 weeks (n=258, 259, 245)	-4.7	—
Insulin Glargine26 weeks (n=255, 255, 244)	0.3	—
52 weeks (n=258, 259, 245)	-1.0	—
78 weeks (n=258, 259, 245)	-2.0	—

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension

Time frame:Baseline, 26, 52, and 78 weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception

Time frame:Baseline, 26, 52, and 78 weeks

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, improvement

Safety / tolerability / PK

16 endpoints

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg26 weeks	160	—
52 weeks	189	—
78 weeks	201	—
LY2189265 0.75 mg26 weeks	146	—
52 weeks	175	—
78 weeks	188	—
Insulin Glargine26 weeks	137	—
52 weeks	175	—
78 weeks	192	—

Secondary/registry result

Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), events	95% CI
LY2189265 1.5 mgSevere HE, 26 weeks	1	—
Severe HE, 52 weeks	1	—
Severe HE, 78 weeks	2	—
Documented symptomatic HE, 26 weeks	311	—
Documented symptomatic HE, 52 weeks	515	—
Documented symptomatic HE, 78 weeks	607	—
Asymptomatic HE, 26 weeks	500	—
Asymptomatic HE, 52 weeks	757	—
Asymptomatic HE, 78 weeks	884	—
Nocturnal HE, 26 weeks	145	—
Nocturnal HE, 52 weeks	185	—
Nocturnal HE, 78 weeks	215	—
Probable symptomatic HE, 26 weeks	11	—
Probable symptomatic HE, 52 weeks	17	—
Probable symptomatic HE, 78 weeks	20	—
LY2189265 0.75 mgSevere HE, 26 weeks	0	—
Severe HE, 52 weeks	0	—
Severe HE, 78 weeks	0	—
Documented symptomatic HE, 26 weeks	315	—
Documented symptomatic HE, 52 weeks	444	—
Documented symptomatic HE, 78 weeks	515	—
Asymptomatic HE, 26 weeks	484	—
Asymptomatic HE, 52 weeks	709	—
Asymptomatic HE, 78 weeks	911	—
Nocturnal HE, 26 weeks	117	—
Nocturnal HE, 52 weeks	147	—
Nocturnal HE, 78 weeks	184	—
Probable symptomatic HE, 26 weeks	19	—
Probable symptomatic HE, 52 weeks	24	—
Probable symptomatic HE, 78 weeks	28	—
Insulin GlargineSevere HE, 26 weeks	1	—
Severe HE, 52 weeks	2	—
Severe HE, 78 weeks	2	—
Documented symptomatic HE, 26 weeks	447	—
Documented symptomatic HE, 52 weeks	789	—
Documented symptomatic HE, 78 weeks	1033	—
Asymptomatic HE, 26 weeks	609	—
Asymptomatic HE, 52 weeks	1093	—
Asymptomatic HE, 78 weeks	1358	—
Nocturnal HE, 26 weeks	240	—
Nocturnal HE, 52 weeks	519	—
Nocturnal HE, 78 weeks	635	—
Probable symptomatic HE, 26 weeks	20	—
Probable symptomatic HE, 52 weeks	22	—
Probable symptomatic HE, 78 weeks	26	—

Secondary/registry result

Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per year	95% CI
LY2189265 1.5 mgSevere HE, 26 weeks	0.01	—
Severe HE, 52 weeks	0.00	—
Severe HE, 78 weeks	0.01	—
Documented symptomatic HE, 26 weeks	2.35	—
Documented symptomatic HE, 52 weeks	2.03	—
Documented symptomatic HE, 78 weeks	1.67	—
Asymptomatic HE, 26 weeks	3.79	—
Asymptomatic HE, 52 weeks	3.08	—
Asymptomatic HE, 78 weeks	2.56	—
Nocturnal HE, 26 weeks	1.23	—
Nocturnal HE, 52 weeks	0.90	—
Nocturnal HE, 78 weeks	0.77	—
Probable symptomatic HE, 26 weeks	0.08	—
Probable symptomatic HE, 52 weeks	0.07	—
Probable symptomatic HE, 78 weeks	0.05	—
LY2189265 0.75 mgSevere HE, 26 weeks	0.00	—
Severe HE, 52 weeks	0.00	—
Severe HE, 78 weeks	0.00	—
Documented symptomatic HE, 26 weeks	2.52	—
Documented symptomatic HE, 52 weeks	1.97	—
Documented symptomatic HE, 78 weeks	1.66	—
Asymptomatic HE, 26 weeks	3.58	—
Asymptomatic HE, 52 weeks	2.68	—
Asymptomatic HE, 78 weeks	2.38	—
Nocturnal HE, 26 weeks	0.96	—
Nocturnal HE, 52 weeks	0.65	—
Nocturnal HE, 78 weeks	0.59	—
Probable symptomatic HE, 26 weeks	0.14	—
Probable symptomatic HE, 52 weeks	0.09	—
Probable symptomatic HE, 78 weeks	0.07	—
Insulin GlargineSevere HE, 26 weeks	0.01	—
Severe HE, 52 weeks	0.01	—
Severe HE, 78 weeks	0.01	—
Documented symptomatic HE, 26 weeks	3.64	—
Documented symptomatic HE, 52 weeks	3.34	—
Documented symptomatic HE, 78 weeks	3.03	—
Asymptomatic HE, 26 weeks	4.82	—
Asymptomatic HE, 52 weeks	4.41	—
Asymptomatic HE, 78 weeks	3.80	—
Nocturnal HE, 26 weeks	1.86	—
Nocturnal HE, 52 weeks	2.07	—
Nocturnal HE, 78 weeks	1.81	—
Probable symptomatic HE, 26 weeks	0.15	—
Probable symptomatic HE, 52 weeks	0.08	—
Probable symptomatic HE, 78 weeks	0.07	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units/liter	95% CI
LY2189265 1.5 mgAmylase (total), 26 weeks	4.000	-4.000 – 13.000
Amylase (total), 52 weeks	4.000	-4.000 – 11.000
Amylase (total), 78 weeks	4.000	-4.000 – 13.000
Amylase (pancreas-derived), 26 weeks	3.000	-1.000 – 8.000
Amylase (pancreas-derived), 52 weeks	3.000	-1.000 – 8.000
Amylase (pancreas-derived), 78 weeks	2.000	-2.000 – 7.000
Lipase, 26 weeks	5.000	-4.000 – 15.000
Lipase, 52 weeks	4.000	-3.000 – 12.000
Lipase, 78 weeks	4.000	-3.000 – 14.000
LY2189265 0.75 mgAmylase (total), 26 weeks	4.000	-3.000 – 11.000
Amylase (total), 52 weeks	5.000	-3.000 – 13.000
Amylase (total), 78 weeks	4.000	-3.000 – 12.000
Amylase (pancreas-derived), 26 weeks	3.000	0.000 – 7.000
Amylase (pancreas-derived), 52 weeks	3.000	-1.000 – 7.000
Amylase (pancreas-derived), 78 weeks	2.000	-1.000 – 7.000
Lipase, 26 weeks	5.000	-1.000 – 15.000
Lipase, 52 weeks	4.000	-2.000 – 11.000
Lipase, 78 weeks	4.000	-1.000 – 13.000
Insulin GlargineAmylase (total), 26 weeks	2.000	-5.000 – 8.000
Amylase (total), 52 weeks	3.000	-5.000 – 9.000
Amylase (total), 78 weeks	1.000	-7.000 – 9.000
Amylase (pancreas-derived), 26 weeks	1.000	-2.000 – 4.000
Amylase (pancreas-derived), 52 weeks	1.000	-2.000 – 6.000
Amylase (pancreas-derived), 78 weeks	0.000	-3.000 – 4.000
Lipase, 26 weeks	-1.000	-6.000 – 5.000
Lipase, 52 weeks	-1.000	-8.000 – 6.000
Lipase, 78 weeks	-2.000	-8.000 – 5.000

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg26 weeks	1	—
52 weeks	2	—
78 weeks	2	—
LY2189265 0.75 mg26 weeks	1	—
52 weeks	1	—
78 weeks	1	—
Insulin Glargine26 weeks	0	—
52 weeks	0	—
78 weeks	0	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin

Time frame:Baseline, 26, 52, and 78 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picogram/milliliter	95% CI
LY2189265 1.5 mg26 weeks (n=266, 267, 258)	0.163	—
52 weeks (n=266, 269, 259)	0.128	—
78 weeks (n=267, 269, 259)	0.086	—
LY2189265 0.75 mg26 weeks (n=266, 267, 258)	0.097	—
52 weeks (n=266, 269, 259)	0.132	—
78 weeks (n=267, 269, 259)	0.035	—
Insulin Glargine26 weeks (n=266, 267, 258)	0.149	—
52 weeks (n=266, 269, 259)	0.176	—
78 weeks (n=267, 269, 259)	0.151	—

Secondary/registry result

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
LY2189265 1.5 mgQTcF interval, 26 weeks (n=240, 245, 229)	-1.71	—
QTcF interval, 52 weeks (n=231, 240, 228)	1.55	—
QTcF interval, 78 weeks (n=221, 220, 222)	1.66	—
PR interval, 26 weeks (n=240, 245, 229)	2.78	—
PR interval, 52 weeks (n=230, 240, 227)	2.61	—
PR interval, 78 weeks (n=221, 220, 222)	2.62	—
LY2189265 0.75 mgQTcF interval, 26 weeks (n=240, 245, 229)	-0.10	—
QTcF interval, 52 weeks (n=231, 240, 228)	1.34	—
QTcF interval, 78 weeks (n=221, 220, 222)	3.44	—
PR interval, 26 weeks (n=240, 245, 229)	2.33	—
PR interval, 52 weeks (n=230, 240, 227)	1.88	—
PR interval, 78 weeks (n=221, 220, 222)	3.27	—
Insulin GlargineQTcF interval, 26 weeks (n=240, 245, 229)	1.24	—
QTcF interval, 52 weeks (n=231, 240, 228)	3.70	—
QTcF interval, 78 weeks (n=221, 220, 222)	4.44	—
PR interval, 26 weeks (n=240, 245, 229)	1.24	—
PR interval, 52 weeks (n=230, 240, 227)	1.50	—
PR interval, 78 weeks (n=221, 220, 222)	1.21	—

Secondary/registry result

Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)

Time frame:Baseline, 26, 52, 78, and 83 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
LY2189265 1.5 mg and 0.75 mg26 weeks	11	—
52 weeks	3	—
78 weeks	1	—
83 weeks	0	—

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks

Time frame:26, 52, and 78 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks

Time frame:Baseline through 26, 52, and 78 weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin

Time frame:Baseline, 26, 52, and 78 weeks

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26, 52, and 78 weeks

change from baseline, descriptive

componentsqtcF interval, pr interval

Secondary/protocol endpoint

Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)

Time frame:Baseline, 26, 52, 78, and 83 weeks

Immunogenicity (ADA)

threshold achievement, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline to 52 and 78 Weeks in Glucagon Concentration

Time frame:Baseline, 52, and 78 weeks

change from baseline, improvement

Publications (3)

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

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 Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).
Diabetes care2015 Dec (month)PMID26089386doi:10.2337/dc14-1625via 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.