AWARD-CHN2

CompletedPhase 3Results posted

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

774

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 19-35•HbA1c 7-11%

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 IDNCT01648582

Org study ID13439

Secondary IDH9X-CR-GBDKEli Lilly and Company

Timeline

Milestones

Study first posted2012-07-24estimated

Results first posted2015-07-24estimated

Last update posted2019-09-18actual

Study start2012-07 (month precision)

Primary completion2014-08actual (month precision)

Study completion2014-12actual (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 mellitus for at least 6 months

•Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks

•Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%

•Adult men or adult non-pregnant, non-breastfeeding women

•Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)

•Stable weight (±5%) ≥3 months prior to screening

Exclusion criteria

•Have type 1 diabetes mellitus

•Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic

•Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide

•Have gastric emptying abnormality

•Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke

•Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)

•Have impaired liver function

•Have impaired kidney function

•Have history of chronic pancreatitis or acute pancreatitis

•Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)

•Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)

Endpoints (44)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular (CV) Events

Time frame:Baseline through 52 weeks

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 with adjudicated CV events	95% CI
1.5 mg Dulaglutide	6	—
0.75 mg Dulaglutide	2	—
Insulin Glargine	2	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular (CV) Events

Time frame:Baseline through 52 weeks

Expanded / custom MACE composite

composite event, event

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

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 26 Weeks, 52 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
1.5 mg DulaglutideWeek 26	-1.47	—
Week 52	-1.08	—
0.75 mg DulaglutideWeek 26	-0.88	—
Week 52	-0.76	—
Insulin GlargineWeek 26	0.97	—
Week 52	1.35	—

p<0.001Mixed Models Analysis

Week 52

Secondary/registry result

Change in Body Mass Index

Time frame:Baseline, 26 Weeks, 52 Weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram/square meter (kg/m2)	95% CI
1.5 mg DulaglutideWeek 26	-0.53	—
Week 52	-0.40	—
0.75 mg DulaglutideWeek 26	-0.32	—
Week 52	-0.27	—
Insulin GlargineWeek 26	0.37	—
Week 52	0.52	—

p<0.001Mixed Models Analysis

Week 26

p<0.001Mixed Models Analysis

Week 52

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 26 Weeks, 52 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Baseline, 26 Weeks, 52 Weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
1.5 mg Dulaglutide	-1.73	—
0.75 mg Dulaglutide	-1.33	—
Insulin Glargine	-1.16	—

Mean Difference (Net)-0.5795% CI-0.74 – -0.40

Mean Difference (Net)-0.1895% CI-0.35 – -0.01

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c at 52 Weeks

Time frame:Baseline, 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
1.5 mg Dulaglutide	-1.47	—
0.75 mg Dulaglutide	-1.03	—
Insulin Glargine	-0.89	—

Mean Difference (Net)-0.5795% CI-0.77 – -0.38

Mean Difference (Net)-0.1395% CI-0.33 – -0.06

Secondary/registry result

Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks

Time frame:Up to 26 and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg DulaglutideHbA1c <7%, Week 26	64.8	—
HbA1c ≤6.5%, Week 26	51.4	—
HbA1c <7%, Week 52	51.8	—
HbA1c ≤6.5%, Week 52	37.2	—
0.75 mg DulaglutideHbA1c <7%, Week 26	52.8	—
HbA1c ≤6.5%, Week 26	38.9	—
HbA1c <7%, Week 52	45.6	—
HbA1c ≤6.5%, Week 52	31.3	—
Insulin GlargineHbA1c <7%, Week 26	40.0	—
HbA1c ≤6.5%, Week 26	21.6	—
HbA1c <7%, Week 52	32.0	—
HbA1c ≤6.5%, Week 52	17.2	—

p<0.001Fisher Exact

\<7.0% Week 26

p0.004Fisher Exact

\<7.0 Week 26

p<0.001Fisher Exact

\<=6.5% Week 26

p<0.001Fisher Exact

\<=6.5% Week 26

p<0.001Fisher Exact

\<7.0% Week 52

p0.002Fisher Exact

\<7.0% Week 52

p<0.001Fisher Exact

\<=6.5% Week 52

p<0.001Fisher Exact

\<=6.5% Week 52

Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 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 DulaglutideChange from baseline in FBG, 26 Weeks	-2.35	—
Change from baseline in FBG, 52 Weeks	-2.23	—
0.75 mg DulaglutideChange from baseline in FBG, 26 Weeks	-1.71	—
Change from baseline in FBG, 52 Weeks	-1.53	—
Insulin GlargineChange from baseline in FBG, 26 Weeks	-2.59	—
Change from baseline in FBG, 52 Weeks	-2.35	—

Mean Difference (Net)0.2495% CI-0.11 – 0.59p0.177Mixed Models Analysis

Week 26

Mean Difference (Net)0.8895% CI0.53 – 1.23p<0.001Mixed Models Analysis

Week 26

Mean Difference (Net)0.1295% CI-0.25 – 0.50p0.518Mixed Models Analysis

Week 52

Mean Difference (Net)0.8295% CI0.45 – 1.20p<0.001Mixed Models Analysis

Week 52

Secondary/registry result

Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 52 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
1.5 mg DulaglutideMorning pre-meal, Week 26	-2.18	—
Morning 2 hours post-meal, Week 26	-3.81	—
Mid-day pre-meal, Week 26	-2.45	—
Mid-day 2 hours post-meal, Week 26	-3.16	—
Evening pre-meal, Week 26	-2.25	—
Evening 2 hours post-meal, Week 26	-3.00	—
Bed time, Week 26	-2.95	—
Morning pre-meal, Week 52	-2.06	—
Morning 2 hours post-meal, Week 52	-3.58	—
Mid-day pre-meal, Week 52	-2.37	—
Mid-day 2 hours post-meal, Week 52	-2.75	—
Evening pre-meal, Week 52	-2.15	—
Evening 2 hours post-meal, Week 52	-2.93	—
Bed time, Week 52	-2.90	—
0.75 mg DulaglutideMorning pre-meal, Week 26	-1.89	—
Morning 2 hours post-meal, Week 26	-3.43	—
Mid-day pre-meal, Week 26	-2.07	—
Mid-day 2 hours post-meal, Week 26	-2.71	—
Evening pre-meal, Week 26	-1.74	—
Evening 2 hours post-meal, Week 26	-2.58	—
Bed time, Week 26	-2.51	—
Morning pre-meal, Week 52	-1.76	—
Morning 2 hours post-meal, Week 52	-3.25	—
Mid-day pre-meal, Week 52	-1.89	—
Mid-day 2 hours post-meal, Week 52	-2.61	—
Evening pre-meal, Week 52	-1.61	—
Evening 2 hours post-meal, Week 52	-2.54	—
Bed time, Week 52	-2.50	—
Insulin GlargineMorning pre-meal, Week 26	-2.83	—
Morning 2 hours post-meal, Week 26	-3.32	—
Mid-day pre-meal, Week 26	-2.10	—
Mid-day 2 hours post-meal, Week 26	-2.11	—
Evening pre-meal, Week 26	-1.62	—
Evening 2 hours post-meal, Week 26	-2.11	—
Bed time, Week 26	-2.16	—
Morning pre-meal, Week 52	-2.83	—
Morning 2 hours post-meal, Week 52	-3.05	—
Mid-day pre-meal, Week 52	-1.94	—
Mid-day 2 hours post-meal, Week 52	-2.12	—
Evening pre-meal, Week 52	-1.51	—
Evening 2 hours post-meal, Week 52	-2.10	—
Bed time, Week 52	-1.91	—

Mean Difference (Net)0.6595% CI0.42 – 0.88p<0.001Mixed Models Analysis

Morning pre-meal, Week 26

Mean Difference (Net)0.9495% CI0.71 – 1.17p<0.001Mixed Models Analysis

Morning pre-meal, Week 26

Mean Difference (Net)-0.4995% CI-0.92 – -0.07p0.024Mixed Models Analysis

Morning 2-hours post-meal, Week 26

Mean Difference (Net)-0.1195% CI-0.53 – 0.32p0.617Mixed Models Analysis

Morning 2-hours post-meal, Week 26

Mean Difference (Net)-0.3595% CI-0.70 – 0.01p0.055Mixed Models Analysis

Mid-day pre-meal, Week 26

Mean Difference (Net)0.0395% CI-0.32 – 0.39p0.855Mixed Models Analysis

Mid-day pre-meal, Week 26

Mean Difference (Net)-1.0595% CI-1.46 – -0.64p<0.001Mixed Models Analysis

Mid-day 2-hours post-meal, Week 26

Mean Difference (Net)-0.6095% CI-1.01 – -0.19p0.004Mixed Models Analysis

Mid-day 2-hours post-meal, Week 26

Mean Difference (Net)-0.6395% CI-0.97 – -0.29p<0.001Mixed Models Analysis

Evening pre-meal, Week 26

Mean Difference (Net)-0.1295% CI-0.45 – 0.22p0.489Mixed Models Analysis

Evening pre-meal, Week 26

Mean Difference (Net)-0.8995% CI-1.30 – -0.48p<0.001Mixed Models Analysis

Evening 2-hours post-meal, Week 26

Mean Difference (Net)-0.4795% CI-0.88 – -0.06p0.024Mixed Models Analysis

Evening 2-hours post-meal, Week 26

Mean Difference (Net)-0.7995% CI-1.17 – -0.41p<0.001Mixed Models Analysis

Bedtime, Week 26

Mean Difference (Net)-0.3595% CI-0.73 – -0.03p0.067Mixed Models Analysis

Bedtime, Week 26

Mean Difference (Net)0.7795% CI0.52 – 1.01p<0.001Mixed Models Analysis

Morning pre-meal, Week 52

Mean Difference (Net)1.0695% CI0.82 – 1.31p<0.001Mixed Models Analysis

Morning pre-meal, Week 52

Mean Difference (Net)-0.5395% CI-1.00 – -0.07p0.025Mixed Models Analysis

Morning 2-hours post-meal, Week 52

Mean Difference (Net)-0.2195% CI-0.67 – 0.26p0.384Mixed Models Analysis

Morning 2-hours post-meal, Week 52

Mean Difference (Net)-0.4395% CI-0.80 – -0.06p0.024Mixed Models Analysis

Mid-day pre-meal, Week 52

Mean Difference (Net)-0.0595% CI-0.32 – 0.42p0.783Mixed Models Analysis

Mid-day pre-meal, Week 52

Mean Difference (Net)-0.6395% CI-1.07 – -0.20p0.004Mixed Models Analysis

Mid-day 2-hours post-meal, Week 52

Mean Difference (Net)-0.4895% CI-0.92 – -0.05p0.029Mixed Models Analysis

Mid-day 2-hours post-meal, Week 52

Mean Difference (Net)-0.6495% CI-1.01 – -0.27p<0.001Mixed Models Analysis

Evening pre-meal, Week 52

Mean Difference (Net)-0.1095% CI-0.47 – 0.27p0.603Mixed Models Analysis

Evening pre-meal, Week 52

Mean Difference (Net)-0.8395% CI-1.26 – -0.41p<0.001Mixed Models Analysis

Evening 2-hours post-meal, Week 52

Mean Difference (Net)-0.4595% CI-0.87 – -0.02p0.039Mixed Models Analysis

Evening 2-hours post-meal, Week 52

Mean Difference (Net)-0.9995% CI-1.39 – -0.60p<0.001Mixed Models Analysis

Bedtime, Week 52

Mean Difference (Net)-0.5995% CI-0.98 – -0.20p0.003Mixed Models Analysis

Bedtime, Week 52

Secondary/registry result

Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA2-%B	95% CI
1.5 mg DulaglutideInsulin-Based HOMA2-%B, 26 Weeks	34.41	—
Insulin-Based HOMA2-%B, 52 Weeks	45.12	—
0.75 mg DulaglutideInsulin-Based HOMA2-%B, 26 Weeks	31.17	—
Insulin-Based HOMA2-%B, 52 Weeks	36.64	—

Mean Difference (Net)34.41p0.352Mixed Models Analysis

HOMA2-%B, Dula 1.5 mg, Week 26

Mean Difference (Net)31.17p0.352Mixed Models Analysis

HOMA2-%B, Dula 0.75 mg, Week 26

Mean Difference (Net)45.12p0.025Mixed Models Analysis

HOMA2-%B, Dula 1.5, Week 52

Mean Difference (Net)36.64p0.025Mixed Models Analysis

HOMA2-%B, Dula 0.75 mg, Week 52

Secondary/registry result

Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 52 Weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA2-%S	95% CI
1.5 mg DulaglutideInsulin-Based HOMA2-%S, Week 26	-6.86	—
Insulin-Based HOMA2-%S, Week 52	-10.19	—
0.75 mg DulaglutideInsulin-Based HOMA2-%S, Week 26	-10.03	—
Insulin-Based HOMA2-%S, Week 52	-12.32	—

Mean Difference (Net)36.57p0.025Mixed Models Analysis

HOMA2-%S, Dula 1.5 mg, Week 26

Mean Difference (Net)30.42p0.025Mixed Models Analysis

HOMA2-%S, Dula 0.75 mg, Week 26

Mean Difference (Net)41.02p0.029Mixed Models Analysis

HOMA2-%S, Dula 1.5 mg, Week 52

Mean Difference (Net)35.19p0.029Mixed Models Analysis

HOMA2-%S, Dula 0.75 mg, Week 52

Secondary/protocol endpoint

Change From Baseline in HbA1c at 52 Weeks

Time frame:Baseline, 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks

Time frame:Up to 26 and 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 52 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 52 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 Weeks, 52 Weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)]	95% CI
1.5 mg DulaglutideSBP 26 Weeks	-5.53	—
DBP 26 Weeks	-1.58	—
SBP 52 Weeks	-2.18	—
DBP 52 Weeks	-0.19	—
0.75 mg DulaglutideSBP 26 Weeks	-2.77	—
DBP 26 Weeks	-0.92	—
SBP 52 Weeks	-0.61	—
DBP 52 Weeks	0.44	—
Insulin GlargineSBP 26 Weeks	-2.22	—
DBP 26 Weeks	-1.61	—
SBP 52 Weeks	-0.25	—
DBP 52 Weeks	-1.13	—

p0.008Mixed Models Analysis

Week 26 SBP

p0.584Mixed Models Analysis

Week 26 DBP

p0.169Mixed Models Analysis

Week 52 SBP

p0.110Mixed Models Analysis

Week 52 DBP

Secondary/registry result

Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate

Time frame:Baseline, 26 Weeks, 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 DulaglutideChange From Baseline on Pulse rate at Week 26	4.63	—
Change From Baseline on Pulse rate at Week 52	4.18	—
0.75 mg DulaglutideChange From Baseline on Pulse rate at Week 26	0.65	—
Change From Baseline on Pulse rate at Week 52	3.18	—
Insulin GlargineChange From Baseline on Pulse rate at Week 26	-0.86	—
Change From Baseline on Pulse rate at Week 52	0.07	—

p<0.001Mixed Models Analysis

Week 26

p<0.001Mixed Models Analysis

Week 52

Secondary/registry result

Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)

Time frame:Baseline, 26 Weeks, 52 Weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute (bpm)	95% CI
1.5 mg DulaglutideWeek 26	6.13	—
Week 52	5.04	—
0.75 mg DulaglutideWeek 26	3.77	—
Week 52	3.40	—
Insulin GlargineWeek 26	-0.46	—
Week 52	0.43	—

Secondary/protocol endpoint

Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate

Time frame:Baseline, 26 Weeks, 52 Weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)

Time frame:Baseline, 26 Weeks, 52 Weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

EQ-5D Health State Score Responses

Time frame:Baseline, 26 Weeks, 52 Weeks

EQ-5D index

descriptive

Posted result

Group	Value (number), participants	95% CI
1.5 mg DulaglutideMobility - no problem Week 26	219	—
Mobility - some problem Week 26	7	—
Mobility - extreme problem Week 26	0	—
Mobility - missing Week 26	4	—
Self-care - no problem Week 26	223	—
Self-care - some problem Week 26	0	—
Self-care - extreme problem Week 26	0	—
Self-care - missing Week 26	4	—
Usual activities - no problems Week 26	219	—
Usual activities - some problems Week 26	7	—
Usual activities - extreme problems Week 26	0	—
Usual activities - missing Week 26	4	—
Pain/Discomfort - no problems Week 26	193	—
Pain/Discomfort - some problems Week 26	32	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing Week 26	4	—
Anxiety/Depression - no problems Week 26	208	—
Anxiety/Depression - some problems Week 26	19	—
Anxiety/Depression - extreme problems Week 26	0	—
Anxiety/Depression - missing Week 26	4	—
Mobility - no problems Week 52	218	—
Mobility - some problems Week 52	8	—
Mobility - extreme problems Week 52	0	—
Mobility - missing Week 52	0	—
Self-care - no problems Week 52	224	—
Self-care - some problems Week 52	2	—
Self-care - extreme problems Week 52	0	—
Self-care - missing Week 52	0	—
Usual Activities - no problems Week 52	219	—
Usual Activities - some problems Week 52	6	—
Usual Activities - extreme problems Week 52	1	—
Usual Activities - missing Week 52	0	—
Pain/Discomfort - no problems Week 52	191	—
Pain/Discomfort - some problems Week 52	34	—
Pain/Discomfort - extreme problems Week 52	1	—
Pain/Discomfort - missing Week 52	0	—
Anxiety/Depression - no problems Week 52	205	—
Anxiety/Depression - some problems Week 52	21	—
Anxiety/Depression - extreme problems Week 52	0	—
Anxiety/Depression - missing Week 52	0	—
0.75 mg DulaglutideMobility - no problem Week 26	215	—
Mobility - some problem Week 26	16	—
Mobility - extreme problem Week 26	0	—
Mobility - missing Week 26	1	—
Self-care - no problem Week 26	227	—
Self-care - some problem Week 26	0	—
Self-care - extreme problem Week 26	0	—
Self-care - missing Week 26	1	—
Usual activities - no problems Week 26	220	—
Usual activities - some problems Week 26	11	—
Usual activities - extreme problems Week 26	0	—
Usual activities - missing Week 26	1	—
Pain/Discomfort - no problems Week 26	201	—
Pain/Discomfort - some problems Week 26	30	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing Week 26	1	—
Anxiety/Depression - no problems Week 26	204	—
Anxiety/Depression - some problems Week 26	27	—
Anxiety/Depression - extreme problems Week 26	0	—
Anxiety/Depression - missing Week 26	1	—
Mobility - no problems Week 52	207	—
Mobility - some problems Week 52	14	—
Mobility - extreme problems Week 52	1	—
Mobility - missing Week 52	0	—
Self-care - no problems Week 52	215	—
Self-care - some problems Week 52	7	—
Self-care - extreme problems Week 52	0	—
Self-care - missing Week 52	0	—
Usual Activities - no problems Week 52	211	—
Usual Activities - some problems Week 52	10	—
Usual Activities - extreme problems Week 52	1	—
Usual Activities - missing Week 52	0	—
Pain/Discomfort - no problems Week 52	188	—
Pain/Discomfort - some problems Week 52	33	—
Pain/Discomfort - extreme problems Week 52	1	—
Pain/Discomfort - missing Week 52	0	—
Anxiety/Depression - no problems Week 52	207	—
Anxiety/Depression - some problems Week 52	15	—
Anxiety/Depression - extreme problems Week 52	0	—
Anxiety/Depression - missing Week 52	0	—
Insulin GlargineMobility - no problem Week 26	210	—
Mobility - some problem Week 26	20	—
Mobility - extreme problem Week 26	0	—
Mobility - missing Week 26	4	—
Self-care - no problem Week 26	224	—
Self-care - some problem Week 26	0	—
Self-care - extreme problem Week 26	0	—
Self-care - missing Week 26	4	—
Usual activities - no problems Week 26	218	—
Usual activities - some problems Week 26	11	—
Usual activities - extreme problems Week 26	0	—
Usual activities - missing Week 26	4	—
Pain/Discomfort - no problems Week 26	188	—
Pain/Discomfort - some problems Week 26	37	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing Week 26	4	—
Anxiety/Depression - no problems Week 26	203	—
Anxiety/Depression - some problems Week 26	26	—
Anxiety/Depression - extreme problems Week 26	1	—
Anxiety/Depression - missing Week 26	4	—
Mobility - no problems Week 52	214	—
Mobility - some problems Week 52	16	—
Mobility - extreme problems Week 52	0	—
Mobility - missing Week 52	1	—
Self-care - no problems Week 52	223	—
Self-care - some problems Week 52	7	—
Self-care - extreme problems Week 52	0	—
Self-care - missing Week 52	1	—
Usual Activities - no problems Week 52	219	—
Usual Activities - some problems Week 52	11	—
Usual Activities - extreme problems Week 52	0	—
Usual Activities - missing Week 52	1	—
Pain/Discomfort - no problems Week 52	185	—
Pain/Discomfort - some problems Week 52	43	—
Pain/Discomfort - extreme problems Week 52	1	—
Pain/Discomfort - missing Week 52	1	—
Anxiety/Depression - no problems Week 52	201	—
Anxiety/Depression - some problems Week 52	29	—
Anxiety/Depression - extreme problems Week 52	0	—
Anxiety/Depression - missing Week 52	1	—

Secondary/registry result

Change From Baseline in EQ-5D Visual Analog Scale Score

Time frame:Baseline, 26 weeks, 52 weeks

EQ-5D VAS

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
1.5 mg DulaglutideWeek 26	1.08	—
Week 52	2.65	—
0.75 mg DulaglutideWeek 26	1.67	—
Week 52	2.34	—
Insulin GlargineWeek 26	1.41	—
Week 52	2.55	—

Secondary/protocol endpoint

EQ-5D Health State Score Responses

Time frame:Baseline, 26 Weeks, 52 Weeks

categorical status, improvement

Secondary/protocol endpoint

Change From Baseline in EQ-5D Visual Analog Scale Score

Time frame:Baseline, 26 weeks, 52 weeks

EQ-5D VAS

change from baseline, improvement

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Rate of Hypoglycemic Events

Time frame:Baseline through 26 weeks and 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per year	95% CI
1.5 mg Dulaglutide1-year Rate of HE, Week 26	1.27	—
Severe HE Week 26	NA	—
Nocturnal HE Week 26	0.19	—
1-year Rate of HE, Week 52	0.89	—
Severe HE Week 52	NA	—
Nocturnal HE Week 52	0.11	—
0.75 mg Dulaglutide1-year Rate of HE, Week 26	0.98	—
Severe HE Week 26	NA	—
Nocturnal HE Week 26	0.13	—
1-year Rate of HE, Week 52	0.80	—
Severe HE Week 52	NA	—
Nocturnal HE Week 52	0.10	—
Insulin Glargine1-year Rate of HE, Week 26	2.13	—
Severe HE Week 26	NA	—
Nocturnal HE Week 26	0.38	—
1-year Rate of HE, Week 52	1.92	—
Severe HE Week 52	NA	—
Nocturnal HE Week 52	0.31	—

Secondary/registry result

Number of Self-reported Hypoglycemic Events

Time frame:Baseline through 26 Weeks and 52 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg DulaglutideTotal HE Week 26	19.4	—
Severe HE Week 26	0.0	—
Nocturnal HE Week 26	6.2	—
Documented Symptomatic Week 26	11.2	—
Asymptomatic HE Week 26	10.1	—
Probable HE Week 26	4.3	—
Total HE Week 52	22.5	—
Severe HE Week 52	0.0	—
Nocturnal HE Week 52	7.0	—
Documented Symptomatic HE Week 52	12.4	—
Asymptomatic HE Week 52	12.0	—
Probable HE Week 52	4.7	—
0.75 mg DulaglutideTotal HE Week 26	16.7	—
Severe HE Week 26	0.0	—
Nocturnal HE Week 26	3.9	—
Documented Symptomatic Week 26	7.8	—
Asymptomatic HE Week 26	8.2	—
Probable HE Week 26	5.1	—
Total HE Week 52	19.8	—
Severe HE Week 52	0.0	—
Nocturnal HE Week 52	4.3	—
Documented Symptomatic HE Week 52	9.7	—
Asymptomatic HE Week 52	10.1	—
Probable HE Week 52	5.4	—
Insulin GlargineTotal HE Week 26	29.6	—
Severe HE Week 26	0.0	—
Nocturnal HE Week 26	11.1	—
Documented Symptomatic Week 26	17.0	—
Asymptomatic HE Week 26	14.2	—
Probable HE Week 26	7.5	—
Total HE Week 52	34.8	—
Severe HE Week 52	0.0	—
Nocturnal HE Week 52	13.8	—
Documented Symptomatic HE Week 52	20.6	—
Asymptomatic HE Week 52	19.4	—
Probable HE Week 52	8.3	—

Secondary/registry result

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

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, descriptive

Posted result

Group	Value (mean), millisecond (msec)	95% CI
1.5 mg DulaglutideQTcF Interval 26 Weeks	-1.65	—
PR Interval 26 Weeks	3.09	—
QTcF Interval 52 Weeks	0.55	—
PR Interval 52 Weeks	3.60	—
0.75 mg DulaglutideQTcF Interval 26 Weeks	0.76	—
PR Interval 26 Weeks	2.88	—
QTcF Interval 52 Weeks	1.19	—
PR Interval 52 Weeks	3.55	—
Insulin GlargineQTcF Interval 26 Weeks	2.56	—
PR Interval 26 Weeks	-0.86	—
QTcF Interval 52 Weeks	4.03	—
PR Interval 52 Weeks	0.63	—

Secondary/registry result

Change From Baseline in Pancreatic Enzymes

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, descriptive

Posted result

Group	Value (mean), Units/Liter (U/L)	95% CI
1.5 mg DulaglutideAmylase, Total 26 Weeks	7.50	—
Amylase, pancreas derived 26 Weeks	5.83	—
Lipase 26 Weeks	11.00	—
Amylase, Total 52 Weeks	7.82	—
Amylase, pancreas derived 52 Weeks	5.48	—
Lipase 52 Weeks	10.76	—
0.75 mg DulaglutideAmylase, Total 26 Weeks	7.54	—
Amylase, pancreas derived 26 Weeks	5.14	—
Lipase 26 Weeks	10.67	—
Amylase, Total 52 Weeks	6.42	—
Amylase, pancreas derived 52 Weeks	4.05	—
Lipase 52 Weeks	9.64	—
Insulin GlargineAmylase, Total 26 Weeks	-0.37	—
Amylase, pancreas derived 26 Weeks	-0.21	—
Lipase 26 Weeks	-2.74	—
Amylase, Total 52 Weeks	0.64	—
Amylase, pancreas derived 52 Weeks	-0.49	—
Lipase 52 Weeks	-3.66	—

Secondary/registry result

Change From Baseline in Serum Calcitonin

Time frame:Baseline, 26 Weeks, 52 Weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picomole/liter	95% CI
1.5 mg DulaglutideWeek 26	0.01	—
Week 52	-0.03	—
0.75 mg DulaglutideWeek 26	-0.07	—
Week 52	-0.08	—
Insulin GlargineWeek 26	0.02	—
Week 52	-0.05	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis

Time frame:Baseline through 52 Weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg Dulaglutide	0	—
0.75 mg Dulaglutide	0	—
Insulin Glargine	0	—

Secondary/registry result

Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)

Time frame:Baseline through 52 Weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	95% CI
1.5 mg DulaglutideParticipants with >=1 TE Dula ADA	3.9	—
Participants with TE Dula ADA and Neutralizing	0.8	—
0.75 mg DulaglutideParticipants with >=1 TE Dula ADA	4.3	—
Participants with TE Dula ADA and Neutralizing	1.6	—
Insulin GlargineParticipants with >=1 TE Dula ADA	1.6	—
Participants with TE Dula ADA and Neutralizing	0.0	—

Secondary/protocol endpoint

Rate of Hypoglycemic Events

Time frame:Baseline through 26 weeks and 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Self-reported Hypoglycemic Events

Time frame:Baseline through 26 Weeks and 52 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

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

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Pancreatic Enzymes

Time frame:Baseline, 26 Weeks, 52 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Serum Calcitonin

Time frame:Baseline, 26 Weeks, 52 Weeks

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis

Time frame:Baseline through 52 Weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)

Time frame:Baseline through 52 Weeks

Immunogenicity (ADA)

threshold achievement, event

Publications (9)

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

Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors.
Diabetes therapy : research, treatment and education of diabetes and related disorders2021 Oct (month)PMID34453682doi:10.1007/s13300-021-01139-2via clinicaltrials gov reference derived + pubmed nct search
Effects of GLP-1 Receptor Agonists on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus: A 52-Week Clinical Study.
BioMed research international2021 (year)PMID34580638doi:10.1155/2021/3361309via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors.
Diabetes therapy : research, treatment and education of diabetes and related disorders2021 Jan (month)PMID33161492doi:10.1007/s13300-020-00955-2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Oct (month)PMID32857293doi:10.1007/s13300-020-00910-1via clinicaltrials gov reference derived + pubmed nct search
Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Aug (month)PMID32621083doi:10.1007/s13300-020-00869-zvia clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 May (month)PMID32277401doi:10.1007/s13300-020-00804-2via clinicaltrials gov reference derived + pubmed nct search
Achieving the composite end-point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once-weekly dulaglutide in Chinese patients with type 2 diabetes: A post-hoc analysis.
Journal of diabetes investigation2020 May (month)PMID31758850doi:10.1111/jdi.13187via pubmed nct search
Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2).
Diabetes therapy : research, treatment and education of diabetes and related disorders2019 Aug (month)PMID31228090doi:10.1007/s13300-019-0646-yvia clinicaltrials gov reference derived + pubmed nct search
The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus.
BioMed research international2019 (year)PMID31950036doi:10.1155/2019/2682657via 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.