CompletedPhase 3Results posted

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

101

Recruiting sites

Actual enrollment

884

Study population

Type 2 diabetes

Eligibility highlights

•BMI 23-45•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01191268

Org study ID11376

Secondary IDH9X-MC-GBDDEli Lilly and Company

Timeline

Milestones

Study first posted2010-08-30estimated

Last update posted2014-10-08estimated

Results first posted2014-10-08estimated

Study start2010-11 (month precision)

Primary completion2012-02actual (month precision)

Study completion2012-09actual (month precision)

Assets

Investigational agents

Dulaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications

•Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%

•Willing to inject subcutaneous medication

•Willing to monitor blood glucose levels and adjust insulin dose

•Willing to maintain a study diary

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

•Stable weight for 3 months prior to screening

•Females of child bearing potential must test negative for pregnancy at screening 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

•Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening

•1 or more episodes of ketoacidosis within 6 months prior to screening

•Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening

•Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening

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

•History of heart failure, New York Heart Classification III or IV within 2 months prior to screening

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

•Acute or chronic hepatitis or pancreatitis

•Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia

•Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening

•Organ transplant except cornea

•Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

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

•Known drug or alcohol abuse

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

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

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

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks

Time frame:Baseline through 52 weeks

Expanded / custom MACE composite

composite event, event

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

Posted result

Group	Number · participants	95% CI
1.5 mg LY2189265Any cardiovascular event	5	-
Any fatal cardiovascular event	0	-
Any non-fatal cardiovascular event	5	-
0.75 mg LY2189265Any cardiovascular event	6	-
Any fatal cardiovascular event	0	-
Any non-fatal cardiovascular event	6	-
Insulin GlargineAny cardiovascular event	12	-
Any fatal cardiovascular event	2	-
Any non-fatal cardiovascular event	11	-

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks

Time frame:Baseline through 52 weeks

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

6 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	Least-squares mean · kilograms (kg)	95% CI
1.5 mg LY218926526 weeks	-0.87	-
52 weeks	-0.35	-
0.75 mg LY218926526 weeks	0.18	-
52 weeks	0.86	-
Insulin Glargine26 weeks	2.33	-
52 weeks	2.89	-

Ls mean difference-3.2095% CI-3.81 - -2.59p<0.001ANCOVA

Ls mean difference-2.1595% CI-2.76 - -1.54p<0.001ANCOVA

Ls mean difference-3.2395% CI-3.99 - -2.48p<0.001ANCOVA

Ls mean difference-2.0395% CI-2.78 - -1.27p<0.001ANCOVA

Secondary/registry result

Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

descriptive

Posted result

Group	Mean · kilograms (kg)	95% CI
1.5 mg LY2189265Baseline	91.00	-
52 weeks (n=290, 290, 295)	91.58	-
4 weeks after last dose (n=259, 260, 253)	91.69	-
0.75 mg LY2189265Baseline	91.69	-
52 weeks (n=290, 290, 295)	93.21	-
4 weeks after last dose (n=259, 260, 253)	93.14	-
Insulin GlargineBaseline	90.75	-
52 weeks (n=290, 290, 295)	94.14	-
4 weeks after last dose (n=259, 260, 253)	94.27	-

Secondary/registry result

Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)

Time frame:Baseline, 26 weeks, and 52 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Least-squares mean · kilograms per meter squared (kg/m^2)	95% CI
1.5 mg LY218926526 weeks (n=248, 251, 250)	-0.20	-
52 weeks (n=225, 224, 232)	0.09	-
4 weeks after last dose	NA	-
0.75 mg LY218926526 weeks (n=248, 251, 250)	0.21	-
52 weeks (n=225, 224, 232)	0.57	-
4 weeks after last dose	NA	-
Insulin Glargine26 weeks (n=248, 251, 250)	1.01	-
52 weeks (n=225, 224, 232)	1.33	-
4 weeks after last dose	NA	-

Ls mean difference-1.2095% CI-1.44 - -0.96p<0.001Mixed Models Analysis

Ls mean difference-0.7995% CI-1.03 - -0.55p<0.001Mixed Models Analysis

Ls mean difference-1.2495% CI-1.55 - -0.94p<0.001Mixed Models Analysis

Ls mean difference-0.7695% CI-1.06 - -0.46p<0.001Mixed Models Analysis

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

Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

descriptive, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)

Time frame:Baseline, 26 weeks, and 52 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

14 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	Least-squares mean · percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-1.64	-
0.75 mg LY2189265	-1.59	-
Insulin Glargine	-1.41	-

Ls mean difference-0.2295% CI-0.38 - -0.07p<0.001ANCOVA

Ls mean difference-0.1795% CI-0.33 - -0.02p<0.001ANCOVA

Ls mean difference-0.2295% CI-0.38 - -0.07p0.005ANCOVA

Superiority analysis.

Ls mean difference-0.1795% CI-0.33 - -0.02p0.015ANCOVA

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	Least-squares mean · percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-1.48	-
0.75 mg LY2189265	-1.42	-
Insulin Glargine	-1.23	-

Ls mean difference-0.2595% CI-0.42 - -0.07p<0.001ANCOVA

Ls mean difference-0.1995% CI-0.37 - -0.02p<0.001ANCOVA

Ls mean difference-0.2595% CI-0.42 - -0.07p0.005ANCOVA

Superiority analysis.

Ls mean difference-0.1995% CI-0.37 - -0.02p0.014ANCOVA

Superiority analysis.

Secondary/registry result

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

Time frame:26 weeks and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
1.5 mg LY2189265HbA1c less than 7.0%, 26 weeks	67.6	-
HbA1c less than 7.0%, 52 weeks	58.5	-
HbA1c less than or equal to 6.5%, 26 weeks	48.0	-
HbA1c less than or equal to 6.5%, 52 weeks	36.7	-
0.75 mg LY2189265HbA1c less than 7.0%, 26 weeks	69.0	-
HbA1c less than 7.0%, 52 weeks	56.3	-
HbA1c less than or equal to 6.5%, 26 weeks	43.0	-
HbA1c less than or equal to 6.5%, 52 weeks	34.7	-
Insulin GlargineHbA1c less than 7.0%, 26 weeks	56.8	-
HbA1c less than 7.0%, 52 weeks	49.3	-
HbA1c less than or equal to 6.5%, 26 weeks	37.5	-
HbA1c less than or equal to 6.5%, 52 weeks	30.4	-

p0.014Regression, Logistic

p0.010Regression, Logistic

p0.027Regression, Logistic

p0.384Regression, Logistic

p<0.05Regression, Logistic

p0.250Regression, Logistic

p0.272Regression, Logistic

p0.623Regression, Logistic

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia

Time frame:Baseline, 26 weeks, and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, hypoglycemia nocturnal absence, hypoglycemia severe absence

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
1.5 mg LY218926526 weeks	53.8	-
52 weeks	44.0	-
0.75 mg LY218926526 weeks	54.5	-
52 weeks	44.0	-
Insulin Glargine26 weeks	28.2	-
52 weeks	26.8	-

p<0.001Regression, Logistic

Secondary/registry result

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

Time frame:Baseline, 26 weeks, and 52 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · millimoles per liter (mmol/L)]	95% CI
1.5 mg LY2189265Pre-morning meal, 26 weeks (n=228, 231, 232)	-0.36	-
Post-morning meal, 26 weeks (n=220, 227, 229)	-3.70	-
Pre-midday meal, 26 weeks (n=227, 231, 233)	-2.80	-
Post-midday meal, 26 weeks (n=219, 227, 228)	-4.51	-
Pre-evening meal, 26 weeks (n=226, 231, 232)	-3.24	-
Post-evening meal, 26 weeks (n=220, 228, 227)	-4.61	-
Bedtime, 26 weeks (n=220, 221, 226)	-4.00	-
After bedtime, 26 weeks (n=208, 216, 208)	-1.48	-
Daily Mean, 26 weeks (n=202, 206, 199)	-3.17	-
Pre-morning meal, 52 weeks (n=207, 213, 218)	0.03	-
Post-morning meal, 52 weeks (n=200, 211, 211)	-3.38	-
Pre-midday meal, 52 weeks (n=207, 213, 218)	-2.53	-
Post-midday meal, 52 weeks (n=202, 210, 212)	-4.33	-
Pre-evening meal, 52 weeks (n=207, 214, 217)	3.00	-
Post-evening meal, 52 weeks (n=200, 210, 212)	-4.22	-
Bedtime, 52 weeks (n=195, 205, 213)	-3.62	-
After bedtime, 52 weeks (n=192, 192 197)	-1.17	-
Daily Mean, 52 weeks (n=182, 185, 189)	-2.84	-
0.75 mg LY2189265Pre-morning meal, 26 weeks (n=228, 231, 232)	-0.06	-
Post-morning meal, 26 weeks (n=220, 227, 229)	-3.29	-
Pre-midday meal, 26 weeks (n=227, 231, 233)	-2.38	-
Post-midday meal, 26 weeks (n=219, 227, 228)	-4.53	-
Pre-evening meal, 26 weeks (n=226, 231, 232)	-3.06	-
Post-evening meal, 26 weeks (n=220, 228, 227)	-4.54	-
Bedtime, 26 weeks (n=220, 221, 226)	-3.89	-
After bedtime, 26 weeks (n=208, 216, 208)	-1.50	-
Daily Mean, 26 weeks (n=202, 206, 199)	-2.97	-
Pre-morning meal, 52 weeks (n=207, 213, 218)	0.05	-
Post-morning meal, 52 weeks (n=200, 211, 211)	-3.23	-
Pre-midday meal, 52 weeks (n=207, 213, 218)	-2.52	-
Post-midday meal, 52 weeks (n=202, 210, 212)	-4.29	-
Pre-evening meal, 52 weeks (n=207, 214, 217)	-3.07	-
Post-evening meal, 52 weeks (n=200, 210, 212)	-4.54	-
Bedtime, 52 weeks (n=195, 205, 213)	-3.96	-
After bedtime, 52 weeks (n=192, 192 197)	-1.36	-
Daily Mean, 52 weeks (n=182, 185, 189)	-2.95	-
Insulin GlarginePre-morning meal, 26 weeks (n=228, 231, 232)	-2.01	-
Post-morning meal, 26 weeks (n=220, 227, 229)	-4.03	-
Pre-midday meal, 26 weeks (n=227, 231, 233)	-2.65	-
Post-midday meal, 26 weeks (n=219, 227, 228)	-3.70	-
Pre-evening meal, 26 weeks (n=226, 231, 232)	-2.74	-
Post-evening meal, 26 weeks (n=220, 228, 227)	-3.90	-
Bedtime, 26 weeks (n=220, 221, 226)	-3.40	-
After bedtime, 26 weeks (n=208, 216, 208)	-1.96	-
Daily Mean, 26 weeks (n=202, 206, 199)	-3.10	-
Pre-morning meal, 52 weeks (n=207, 213, 218)	-2.02	-
Post-morning meal, 52 weeks (n=200, 211, 211)	-3.76	-
Pre-midday meal, 52 weeks (n=207, 213, 218)	-2.63	-
Post-midday meal, 52 weeks (n=202, 210, 212)	-3.83	-
Pre-evening meal, 52 weeks (n=207, 214, 217)	-2.67	-
Post-evening meal, 52 weeks (n=200, 210, 212)	-3.71	-
Bedtime, 52 weeks (n=195, 205, 213)	-3.27	-
After bedtime, 52 weeks (n=192, 192 197)	-1.80	-
Daily Mean, 52 weeks (n=182, 185, 189)	-2.97	-

Ls mean difference-0.0795% CI-0.35 - 0.21p0.628Mixed Models Analysis

Ls mean difference0.1395% CI-0.15 - 0.41p0.368Mixed Models Analysis

Ls mean difference0.1395% CI-0.16 - 0.42p0.370Mixed Models Analysis

Ls mean difference0.0295% CI-0.26 - 0.30p0.879Mixed Models Analysis

Secondary/registry result

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

Time frame:Baseline, 26 weeks, and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · millimoles per liter (mmol/L)	95% CI
1.5 mg LY218926526 weeks (n=253, 256, 255)	-0.27	-
52 weeks (n=237, 238, 246)	0.08	-
0.75 mg LY218926526 weeks (n=253, 256, 255)	0.22	-
52 weeks (n=237, 238, 246)	0.41	-
Insulin Glargine26 weeks (n=253, 256, 255)	-1.58	-
52 weeks (n=237, 238, 246)	-1.01	-

Ls mean difference1.3195% CI0.83 - 1.79p<0.001Mixed Models Analysis

Ls mean difference1.8095% CI1.32 - 2.28p<0.001Mixed Models Analysis

Ls mean difference1.0995% CI0.55 - 1.64p<0.001Mixed Models Analysis

Ls mean difference1.4295% CI0.88 - 1.96p<0.001Mixed Models Analysis

Secondary/registry result/low confidence

Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)

Time frame:Baseline and 26 weeks and 52 weeks

change from baseline, improvement

componentsinsulin lispro dose, insulin glargine dose

Posted result

Group	Mean · units	95% CI
1.5 mg LY2189265TDI, Baseline	55.20	-
TDI, 26 weeks (n=244, 251, 254)	93.24	-
TDI, 52 weeks (n=224, 227, 238)	88.15	-
Insulin Lispro, 26 weeks (n=244, 251, 254)	93.24	-
Insulin Lispro, 52 weeks (n=224, 227, 238)	88.15	-
Insulin Glargine, 26 weeks (n=244, 251, 254)	NA	-
Insulin Glargine, 52 weeks (n=224, 227, 238)	NA	-
0.75 mg LY2189265TDI, Baseline	59.11	-
TDI, 26 weeks (n=244, 251, 254)	96.69	-
TDI, 52 weeks (n=224, 227, 238)	95.00	-
Insulin Lispro, 26 weeks (n=244, 251, 254)	96.69	-
Insulin Lispro, 52 weeks (n=224, 227, 238)	95.00	-
Insulin Glargine, 26 weeks (n=244, 251, 254)	NA	-
Insulin Glargine, 52 weeks (n=224, 227, 238)	NA	-
Insulin GlargineTDI, Baseline	53.93	-
TDI, 26 weeks (n=244, 251, 254)	132.00	-
TDI, 52 weeks (n=224, 227, 238)	133.19	-
Insulin Lispro, 26 weeks (n=244, 251, 254)	67.79	-
Insulin Lispro, 52 weeks (n=224, 227, 238)	69.12	-
Insulin Glargine, 26 weeks (n=244, 251, 254)	64.48	-
Insulin Glargine, 52 weeks (n=224, 227, 238)	64.07	-

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 Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52

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 the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia

Time frame:Baseline, 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 Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

Time frame:Baseline, 26 weeks, and 52 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 26 weeks, and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)

Time frame:Baseline and 26 weeks and 52 weeks

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

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

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Least-squares mean · milliliters of mercury (mmHg)	95% CI
1.5 mg LY2189265SBP, 26 weeks (n=255, 261, 258)	-0.97	-
SBP, 52 weeks (n=239, 240, 246)	-0.26	-
DBP, 26 weeks (n=255, 261, 258)	0.02	-
DBP, 52 weeks (n=239, 240, 246)	-0.01	-
0.75 mg LY2189265SBP, 26 weeks (n=255, 261, 258)	-0.65	-
SBP, 52 weeks (n=239, 240, 246)	1.04	-
DBP, 26 weeks (n=255, 261, 258)	-0.08	-
DBP, 52 weeks (n=239, 240, 246)	0.15	-
Insulin GlargineSBP, 26 weeks (n=255, 261, 258)	2.23	-
SBP, 52 weeks (n=239, 240, 246)	1.98	-
DBP, 26 weeks (n=255, 261, 258)	-0.23	-
DBP, 52 weeks (n=239, 240, 246)	-0.34	-

Secondary/registry result

Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

descriptive, improvement

Posted result

Group	Mean · milliliters of mercury (mmHg)	95% CI
1.5 mg LY2189265SBP, Baseline	133.26	-
SBP, 52 weeks (n=290, 290, 295)	132.67	-
SBP, 4 weeks after last dose (n=260, 260, 255)	133.77	-
DBP, Baseline	77.33	-
DBP, 52 weeks (n=290, 290, 295)	77.33	-
DBP, 4 weeks after last dose (n=260, 260, 255)	76.58	-
0.75 mg LY2189265SBP, Baseline	134.03	-
SBP, 52 weeks (n=290, 290, 295)	134.31	-
SBP, 4 weeks after last dose (n=260, 260, 255)	134.72	-
DBP, Baseline	77.57	-
DBP, 52 weeks (n=290, 290, 295)	77.59	-
DBP, 4 weeks after last dose (n=260, 260, 255)	77.04	-
Insulin GlargineSBP, Baseline	133.26	-
SBP, 52 weeks (n=290, 290, 295)	134.90	-
SBP, 4 weeks after last dose (n=260, 260, 255)	132.75	-
DBP, Baseline	77.18	-
DBP, 52 weeks (n=290, 290, 295)	77.07	-
DBP, 4 weeks after last dose (n=260, 260, 255)	76.94	-

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	Least-squares mean · beats per minute (bpm)	95% CI
1.5 mg LY218926526 weeks (n=255, 261, 258)	2.84	-
52 weeks (n=239, 240, 246)	2.38	-
0.75 mg LY218926526 weeks (n=255, 261, 258)	2.79	-
52 weeks (n=239, 240, 246)	2.27	-
Insulin Glargine26 weeks (n=255, 261, 258)	0.90	-
52 weeks (n=239, 240, 246)	0.93	-

Secondary/registry result

Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · beats per minute (bpm)	95% CI
1.5 mg LY2189265Baseline	75.26	-
52 weeks (n=290, 290, 295)	78.30	-
4 weeks after last dose (n=260, 260, 255)	74.52	-
0.75 mg LY2189265Baseline	75.08	-
52 weeks (n=290, 290, 295)	77.83	-
4 weeks after last dose (n=260, 260, 255)	74.99	-
Insulin GlargineBaseline	74.54	-
52 weeks (n=290, 290, 295)	76.02	-
4 weeks after last dose (n=260, 260, 255)	75.27	-

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	Least-squares mean · beats per minute (bpm)	95% CI
1.5 mg LY218926526 weeks (n=244, 246, 243)	3.95	-
52 weeks (n=230, 226, 230)	3.02	-
0.75 mg LY218926526 weeks (n=244, 246, 243)	4.18	-
52 weeks (n=230, 226, 230)	3.83	-
Insulin Glargine26 weeks (n=244, 246, 243)	1.37	-
52 weeks (n=230, 226, 230)	1.03	-

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in Blood Pressure

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

descriptive, 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

Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

Heart rate, change

change from baseline, improvement

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

Patient-reported / QoL

8 endpoints

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the EQ-5D

Time frame:Baseline, 26 weeks, and 52 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Least-squares mean · units on a scale	95% CI
1.5 mg LY2189265EQ-5D UK, 26 weeks (n=272, 271, 274)	-0.03	-
EQ-5D UK, 52 weeks (n=274, 274, 281)	-0.04	-
VAS, 26 weeks (n=278, 275, 275)	-1.69	-
VAS, 52 weeks (n=279, 278, 282)	-0.46	-
0.75 mg LY2189265EQ-5D UK, 26 weeks (n=272, 271, 274)	-0.03	-
EQ-5D UK, 52 weeks (n=274, 274, 281)	-0.04	-
VAS, 26 weeks (n=278, 275, 275)	-2.30	-
VAS, 52 weeks (n=279, 278, 282)	-2.54	-
Insulin GlargineEQ-5D UK, 26 weeks (n=272, 271, 274)	-0.03	-
EQ-5D UK, 52 weeks (n=274, 274, 281)	-0.03	-
VAS, 26 weeks (n=278, 275, 275)	-0.60	-
VAS, 52 weeks (n=279, 278, 282)	-0.18	-

Secondary/registry result

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

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · units on a scale	95% CI
1.5 mg LY218926526 weeks (n=274, 270, 270)	-0.50	-
52 weeks (n=277, 275, 279)	-0.50	-
0.75 mg LY218926526 weeks (n=274, 270, 270)	-0.60	-
52 weeks (n=277, 275, 279)	-1.05	-
Insulin Glargine26 weeks (n=274, 270, 270)	-0.93	-
52 weeks (n=277, 275, 279)	-1.28	-

Secondary/registry result

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

Time frame:Baseline, 26 weeks, and 52 weeks

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Least-squares mean · units on a scale	95% CI
1.5 mg LY218926526 weeks (n=277, 274, 274)	0.60	-
52 weeks (n=278, 277, 281)	0.86	-
0.75 mg LY218926526 weeks (n=277, 274, 274)	0.34	-
52 weeks (n=278, 277, 281)	0.22	-
Insulin Glargine26 weeks (n=277, 274, 274)	0.18	-
52 weeks (n=278, 277, 281)	0.06	-

Secondary/registry result

Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · units on a scale	95% CI
1.5 mg LY218926526 weeks (n=251, 256, 250)	3.75	-
52 weeks (n=234, 238, 244)	2.51	-
0.75 mg LY218926526 weeks (n=251, 256, 250)	2.91	-
52 weeks (n=234, 238, 244)	0.92	-
Insulin Glargine26 weeks (n=251, 256, 250)	2.83	-
52 weeks (n=234, 238, 244)	2.38	-

Secondary/protocol endpoint

Change From Baseline to 26 and 52 Weeks in the EQ-5D

Time frame:Baseline, 26 weeks, and 52 weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

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

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)

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 Low Blood Sugar Survey (LBSS)

Time frame:Baseline, 26 weeks, and 52 weeks

change from baseline, improvement

Safety / tolerability / PK

20 endpoints

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	Median · units per liter (U/L)	95% CI
1.5 mg LY2189265Amylase (total), 26 weeks (n=284, 282, 287)	5.00	-2.00 - 15.00
Amylase (total), 52 weeks (n=284, 283, 287)	2.00	-3.00 - 12.00
Amylase (PD), 26 weeks (n=284, 282, 287)	4.00	0.00 - 10.00
Amylase (PD), 52 weeks (n=284, 283, 287)	3.00	-2.00 - 9.00
Lipase, 26 weeks (n=284, 282, 287)	7.00	0.00 - 17.00
Lipase, 52 weeks (n=284, 283, 287)	6.00	-1.00 - 16.50
0.75 mg LY2189265Amylase (total), 26 weeks (n=284, 282, 287)	4.00	-1.00 - 10.00
Amylase (total), 52 weeks (n=284, 283, 287)	2.00	-4.00 - 9.00
Amylase (PD), 26 weeks (n=284, 282, 287)	2.50	0.00 - 7.00
Amylase (PD), 52 weeks (n=284, 283, 287)	2.00	-2.00 - 5.00
Lipase, 26 weeks (n=284, 282, 287)	4.00	-3.00 - 12.00
Lipase, 52 weeks (n=284, 283, 287)	3.00	-3.00 - 11.00
Insulin GlargineAmylase (total), 26 weeks (n=284, 282, 287)	1.00	-4.00 - 8.00
Amylase (total), 52 weeks (n=284, 283, 287)	0.00	-7.00 - 6.00
Amylase (PD), 26 weeks (n=284, 282, 287)	1.00	-2.00 - 4.00
Amylase (PD), 52 weeks (n=284, 283, 287)	0.00	-3.00 - 3.00
Lipase, 26 weeks (n=284, 282, 287)	-2.00	-8.00 - 3.00
Lipase, 52 weeks (n=284, 283, 287)	-2.00	-9.00 - 4.00

Secondary/registry result

Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

concentration, descriptive

Posted result

Group	Mean · units per liter (U/L)	95% CI
1.5 mg LY2189265Amylase (total), Baseline	61.21	-
Amylase (total), 52 weeks (n=284, 283, 287)	66.08	-
Amylase (total), 4 weeks ALD (n=251, 259, 251)	61.69	-
Amylase (PD), Baseline	26.56	-
Amylase (PD), 52 weeks (n=284, 283, 287)	31.38	-
Amylase (PD), 4 weeks ALD (n=251, 260, 251)	27.50	-
Lipase, Baseline	41.42	-
Lipase, 52 weeks (n=284, 283, 287)	50.57	-
Lipase, 4 weeks ALD (n=252, 260, 251)	44.19	-
0.75 mg LY2189265Amylase (total), Baseline	58.59	-
Amylase (total), 52 weeks (n=284, 283, 287)	60.97	-
Amylase (total), 4 weeks ALD (n=251, 259, 251)	59.21	-
Amylase (PD), Baseline	25.10	-
Amylase (PD), 52 weeks (n=284, 283, 287)	27.86	-
Amylase (PD), 4 weeks ALD (n=251, 260, 251)	25.77	-
Lipase, Baseline	41.08	-
Lipase, 52 weeks (n=284, 283, 287)	45.34	-
Lipase, 4 weeks ALD (n=252, 260, 251)	41.86	-
Insulin GlargineAmylase (total), Baseline	61.18	-
Amylase (total), 52 weeks (n=284, 283, 287)	61.93	-
Amylase (total), 4 weeks ALD (n=251, 259, 251)	62.13	-
Amylase (PD), Baseline	26.43	-
Amylase (PD), 52 weeks (n=284, 283, 287)	26.91	-
Amylase (PD), 4 weeks ALD (n=251, 260, 251)	26.84	-
Lipase, Baseline	43.20	-
Lipase, 52 weeks (n=284, 283, 287)	39.39	-
Lipase, 4 weeks ALD (n=252, 260, 251)	43.02	-

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	Median · picogram per milliliter (pcg/mL)	95% CI
1.5 mg LY218926526 weeks (n=283, 282, 285)	0.00	0.00 - 0.00
52 weeks (n=283, 283, 285)	0.00	0.00 - 0.00
0.75 mg LY218926526 weeks (n=283, 282, 285)	0.00	0.00 - 0.00
52 weeks (n=283, 283, 285)	0.00	0.00 - 0.00
Insulin Glargine26 weeks (n=283, 282, 285)	0.00	0.00 - 0.00
52 weeks (n=283, 283, 285)	0.00	0.00 - 0.00

Secondary/registry result

Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

Thyroid event

descriptive

Posted result

Group	Mean · picomole per liter	95% CI
1.5 mg LY2189265Baseline	0.75	-
52 weeks (n=284, 283, 285)	0.79	-
4 weeks after last dose (n=245, 254, 246)	0.76	-
0.75 mg LY2189265Baseline	0.73	-
52 weeks (n=284, 283, 285)	0.78	-
4 weeks after last dose (n=245, 254, 246)	0.73	-
Insulin GlargineBaseline	0.78	-
52 weeks (n=284, 283, 285)	0.80	-
4 weeks after last dose (n=245, 254, 246)	0.87	-

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

Posted result

Group	Least-squares mean · milliseconds (msec)	95% CI
1.5 mg LY2189265QTcF interval, 26 weeks (n=241, 242, 236)	0.29	-
QTcF interval, 52 weeks (n= 222, 221, 221)	1.89	-
PR interval, 26 weeks (n=238, 243, 236)	0.82	-
PR interval, 52 weeks (n=220, 222, 221)	0.85	-
0.75 mg LY2189265QTcF interval, 26 weeks (n=241, 242, 236)	0.30	-
QTcF interval, 52 weeks (n= 222, 221, 221)	1.48	-
PR interval, 26 weeks (n=238, 243, 236)	-1.75	-
PR interval, 52 weeks (n=220, 222, 221)	0.05	-
Insulin GlargineQTcF interval, 26 weeks (n=241, 242, 236)	1.59	-
QTcF interval, 52 weeks (n= 222, 221, 221)	1.80	-
PR interval, 26 weeks (n=238, 243, 236)	-1.13	-
PR interval, 52 weeks (n=220, 222, 221)	-0.43	-

Secondary/registry result

Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 52 weeks

Pancreatitis

event count, event

Posted result

Group	Number · events	95% CI
1.5 mg LY218926526 weeks	NA	-
52 weeks	0	-
4 weeks after last dose	NA	-
0.75 mg LY218926526 weeks	NA	-
52 weeks	0	-
4 weeks after last dose	NA	-
Insulin Glargine26 weeks	NA	-
52 weeks	0	-
4 weeks after last dose	NA	-

Secondary/registry result

Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 26 weeks and 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · participants	95% CI
1.5 mg LY2189265Severe HE, 26 weeks	4	-
Severe HE, 52 weeks	8	-
Severe HE, 4 weeks after last dose	NA	-
Documented Symptomatic HE, 26 weeks	228	-
Documented Symptomatic HE, 52 weeks	235	-
Documented Symptomatic HE, 4 weeks after last dose	NA	-
Asymptomatic HE, 26 weeks	174	-
Asymptomatic HE, 52 weeks	191	-
Asymptomatic HE, 4 weeks after last dose	NA	-
Total HE, 26 weeks	250	-
Total HE, 52 weeks	252	-
Total HE, 4 weeks after last dose	NA	-
0.75 mg LY2189265Severe HE, 26 weeks	5	-
Severe HE, 52 weeks	7	-
Severe HE, 4 weeks after last dose	NA	-
Documented Symptomatic HE, 26 weeks	242	-
Documented Symptomatic HE, 52 weeks	250	-
Documented Symptomatic HE, 4 weeks after last dose	NA	-
Asymptomatic HE, 26 weeks	179	-
Asymptomatic HE, 52 weeks	196	-
Asymptomatic HE, 4 weeks after last dose	NA	-
Total HE, 26 weeks	258	-
Total HE, 52 weeks	263	-
Total HE, 4 weeks after last dose	NA	-
Insulin GlargineSevere HE, 26 weeks	9	-
Severe HE, 52 weeks	14	-
Severe HE, 4 weeks after last dose	NA	-
Documented Symptomatic HE, 26 weeks	243	-
Documented Symptomatic HE, 52 weeks	247	-
Documented Symptomatic HE, 4 weeks after last dose	NA	-
Asymptomatic HE, 26 weeks	198	-
Asymptomatic HE, 52 weeks	207	-
Asymptomatic HE, 4 weeks after last dose	NA	-
Total HE, 26 weeks	264	-
Total HE, 52 weeks	266	-
Total HE, 4 weeks after last dose	NA	-

Secondary/registry result

Rate of Self-reported Hypoglycemic Events up to 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Mean · events per participant per year	95% CI
1.5 mg LY2189265Severe HE	0.03	-
Documented Symptomatic HE	30.98	-
Asymptomatic HE	9.55	-
Total HE	41.52	-
0.75 mg LY2189265Severe HE	0.05	-
Documented Symptomatic HE	35.03	-
Asymptomatic HE	11.56	-
Total HE	47.42	-
Insulin GlargineSevere HE	0.08	-
Documented Symptomatic HE	39.90	-
Asymptomatic HE	14.20	-
Total HE	55.93	-

Secondary/registry result

Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 4 weeks after last dose

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Number · participants	95% CI
1.5 mg or 0.75 mg LY218926526 weeks	NA	-
52 weeks	NA	-
4 weeks after last dose	9	-

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · participants	95% CI
1.5 mg LY218926526 weeks	203	-
52 weeks	217	-
4 weeks after last dose	223	-
0.75 mg LY218926526 weeks	216	-
52 weeks	230	-
4 weeks after last dose	235	-
Insulin Glargine26 weeks	178	-
52 weeks	206	-
4 weeks after last dose	211	-

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

Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

concentration, 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, descriptive

Secondary/protocol endpoint

Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline and 52 weeks and 4 weeks after last dose

Thyroid event

descriptive

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

Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 52 weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 26 weeks and 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events up to 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 4 weeks after last dose

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Time frame:Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose

Treatment-emergent AEs (any)

event count, event

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

Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration.
Diabetes, obesity & metabolism2018 Jun (month)PMID29430801doi:10.1111/dom.13252via 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
Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study.
Lancet (London, England)2015 May 23PMID26009229doi:10.1016/S0140-6736(15)60936-9via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.