AWARD-CHN1

CompletedPhase 3Results posted

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

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

737

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 19-35•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

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

Identifiers

Registered as

NCT IDNCT01644500

Org study ID11991

Secondary IDH9X-JE-GBCGEli Lilly and Company

Timeline

Milestones

Study first posted2012-07-19estimated

Results first posted2015-12-17estimated

Last update posted2019-09-18actual

Study start2012-07 (month precision)

Primary completion2014-08actual (month precision)

Study completion2014-08actual (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 mellitus

•OAM-naïve or have been taking OAM monotherapy for at least 3 months

•Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy

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

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

•Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m^2)

Exclusion criteria

•Have type 1 diabetes mellitus

•Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening

•Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening

•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 millimeters 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 picogram/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 (42)

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

Weight & body composition

Patient-reported / QoL

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events

Time frame:Baseline through 26 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), number of participants	95% CI
1.5 mg Dulaglutide	0	—
0.75 mg Dulaglutide	1	—
Glimepiride	0	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events

Time frame:Baseline through 26 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 at 26 Weeks

Time frame:Baseline, 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
1.5 mg Dulaglutide	-1.46	—
0.75 mg Dulaglutide	-0.77	—
Glimepiride	0.89	—

p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) at 26 Weeks

Time frame:Baseline, 26 Weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per meter squared (kg/m^2)	95% CI
1.5 mg Dulaglutide	-0.55	—
0.75 mg Dulaglutide	-0.29	—
Glimepiride	0.32	—

p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at 26 Weeks

Time frame:Baseline, 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at 26 Weeks

Time frame:Baseline, 26 Weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline in 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	-1.48	—
0.75 mg Dulaglutide	-1.22	—
Glimepiride	-0.92	—

Mean Difference (Net)-0.5895% CI-0.76 – -0.39p<0.001Mixed Models Analysis

Mean Difference (Net)-0.3295% CI-0.50 – -0.13p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in HbA1c at 26 Weeks

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

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

Time frame:26 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg DulaglutideHbA1c ≤6.5%	59.4	—
HbA1c <7.0%	74.1	—
0.75 mg DulaglutideHbA1c ≤6.5%	47.7	—
HbA1c <7.0%	63.6	—
GlimepirideHbA1c ≤6.5%	41.3	—
HbA1c <7.0%	57.4	—

Odds Ratio (OR)2.705% CI1.8 – 4.1p<0.001Fisher Exact

Odds Ratio (OR)1.695% CI1.0 – 2.3p<0.001Fisher Exact

Odds Ratio (OR)2.995% CI1.8 – 4.5p<0.001Fisher Exact

Odds Ratio (OR)1.695% CI1.1 – 2.5p0.192Fisher Exact

Secondary/registry result

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

Time frame:Baseline, 26 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 Dulaglutide	-2.71	—
0.75 mg Dulaglutide	-2.26	—
Glimepiride	-1.89	—

Mean Difference (Net)-0.8395% CI-1.15 – -0.51p<0.001Mixed Models Analysis

Mean Difference (Net)-0.3895% CI-0.70 – -0.05p0.022Mixed Models Analysis

Secondary/registry result

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

Time frame:Baseline, 26 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
1.5 mg DulaglutideMorning (fasting)	-2.47	—
Morning (2 hours post-prandial) meal	-4.56	—
Midday (pre-prandial) meal	-3.09	—
Midday (2 hours post-prandial) meal	-4.15	—
Evening (pre-prandial) meal	-2.36	—
Evening (2 hours post-prandial) meal	-3.63	—
Bedtime	-3.22	—
0.75 mg DulaglutideMorning (fasting)	-1.91	—
Morning (2 hours post-prandial) meal	-3.75	—
Midday (pre-prandial) meal	-2.43	—
Midday (2 hours post-prandial) meal	-3.40	—
Evening (pre-prandial) meal	-1.77	—
Evening (2 hours post-prandial) meal	-2.80	—
Bedtime	-2.69	—
GlimepirideMorning (fasting)	-1.80	—
Morning (2 hours post-prandial) meal	-3.20	—
Midday (pre-prandial) meal	-2.37	—
Midday (2 hours post-prandial) meal	-2.58	—
Evening (pre-prandial) meal	-1.69	—
Evening (2 hours post-prandial) meal	-2.35	—
Bedtime	-2.03	—

Mean Difference (Net)-0.6795% CI-0.89 – -0.45p<0.001Mixed Models Analysis

Mean Difference (Net)-0.1295% CI-0.34 – 0.11p0.304Mixed Models Analysis

Mean Difference (Net)-1.3695% CI-1.80 – -0.92p<0.001Mixed Models Analysis

Mean Difference (Net)-0.5595% CI-0.99 – -0.11p0.015Mixed Models Analysis

Mean Difference (Net)-0.7395% CI-1.10 – -0.36p<0.001Mixed Models Analysis

Mean Difference (Net)-0.0695% CI-0.43 – 0.31p0.740Mixed Models Analysis

Mean Difference (Net)-1.5695% CI-1.99 – -1.13p<0.001Mixed Models Analysis

Mean Difference (Net)-0.8195% CI-1.24 – -0.39p<0.001Mixed Models Analysis

Mean Difference (Net)-0.6795% CI-1.00 – -0.34p<0.001Mixed Models Analysis

Mean Difference (Net)-0.0895% CI-0.41 – 0.25p0.638Mixed Models Analysis

Mean Difference (Net)-1.2795% CI-1.68 – -0.87p<0.001Mixed Models Analysis

Mean Difference (Net)-0.4595% CI-0.85 – -0.04p0.030Mixed Models Analysis

Mean Difference (Net)-1.1995% CI-1.56 – -0.82p<0.001Mixed Models Analysis

Mean Difference (Net)-0.6695% CI-1.03 – -0.29p<0.001Mixed Models Analysis

Secondary/registry result

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

Time frame:Baseline, up to 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA2-%B	95% CI
1.5 mg DulaglutideInsulin-based HOMA-2%B	47.40	—
C-peptide HOMA-2%B	41.02	—
0.75 mg DulaglutideInsulin-based HOMA-2%B	37.92	—
C-peptide HOMA-2%B	34.57	—
GlimepirideInsulin-based HOMA-2%B	30.00	—
C-peptide HOMA-2%B	24.58	—

Mean Difference (Net)17.4195% CI11.27 – 23.55p<0.001ANCOVA

Insulin HOMA2-%B

Mean Difference (Net)7.9295% CI1.78 – 14.06p0.012ANCOVA

Insulin HOMA2%B

Mean Difference (Net)16.4495% CI11.81 – 21.06p<0.001ANCOVA

C-Peptide-Based HOMA2-%B

Mean Difference (Net)9.9995% CI5.36 – 14.62p<0.001ANCOVA

C-Peptide-Based HOMA2-%B

Secondary/registry result

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

Time frame:Baseline, up to 26 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	-6.85	—
C-Peptide-Based HOMA2-%S	-6.44	—
0.75 mg DulaglutideInsulin-Based HOMA2-%S	-10.33	—
C-Peptide-Based HOMA2-%S	-11.84	—
GlimepirideInsulin-Based HOMA2-%S	-7.19	—
C-Peptide-Based HOMA2-%S	-5.05	—

Mean Difference (Net)0.3495% CI-5.83 – 6.51p0.913ANCOVA

Insulin-Based HOMA2%S

Mean Difference (Net)-3.1495% CI-9.30 – 3.03p0.318ANCOVA

Insulin-Based HOMA2%S

Mean Difference (Net)-1.3995% CI-6.27 – 3.49p0.576ANCOVA

C-Peptide-Based HOMA2-%S

Mean Difference (Net)-6.7995% CI-11.68 – -1.89p0.007ANCOVA

C-Peptide-Based HOMA2-%S

Secondary/protocol endpoint

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

Time frame:26 Weeks

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

Secondary/protocol endpoint

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

Time frame:Baseline, 26 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

Time frame:Baseline, 26 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

Time frame:Baseline, up to 26 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

Time frame:Baseline, up to 26 Weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change From Baseline in Sitting Blood Pressure at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 mg DulaglutideSBP	-2.07	—
DBP	-0.10	—
0.75 mg DulaglutideSBP	-1.88	—
DBP	-0.11	—
GlimepirideSBP	-0.66	—
DBP	0.15	—

p0.180Mixed Models Analysis

p0.245Mixed Models Analysis

p0.717Mixed Models Analysis

p0.619Mixed Models Analysis

Secondary/registry result

Change From Baseline in Sitting Pulse Rate at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg Dulaglutide	3.07	—
0.75 mg Dulaglutide	1.24	—
Glimepiride	-0.34	—

p<0.001Mixed Models Analysis

p0.035Mixed Models Analysis

Secondary/registry result

Change From Baseline in Heart Rate From ECG at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), bpm	95% CI
1.5 mg Dulaglutide	3.99	—
0.75 mg Dulaglutide	1.90	—
Glimepiride	0.44	—

Secondary/protocol endpoint

Change From Baseline in Sitting Blood Pressure at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Sitting Pulse Rate at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Heart Rate From ECG at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks

Time frame:Week 26

EQ-5D index

categorical status, improvement

Posted result

Group	Value (number), participants	95% CI
1.5 mg DulaglutideMobility - no problem	217	—
Mobility - some problem	4	—
Mobility - extreme problem	0	—
Mobility - ambiguous	0	—
Mobility - missing	1	—
Self-care - no problem	221	—
Self-care - some problem	0	—
Self-care - extreme problem	0	—
Self-care - ambiguous	0	—
Self-care - missing	1	—
Usual activities - no problems	221	—
Usual activities - some problems	0	—
Usual activities - extreme problems	0	—
Usual activities - ambiguous	0	—
Usual activities - missing	1	—
Pain/Discomfort - no problems	198	—
Pain/Discomfort - some problems	23	—
Pain/Discomfort - extreme problems	0	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing	1	—
Anxiety/Depression - no problems	208	—
Anxiety/Depression - some problems	13	—
Anxiety/Depression - extreme problems	0	—
Anxiety/Depression - ambiguous	0	—
Anxiety/Depression - missing	1	—
0.75 mg DulaglutideMobility - no problem	218	—
Mobility - some problem	3	—
Mobility - extreme problem	0	—
Mobility - ambiguous	0	—
Mobility - missing	3	—
Self-care - no problem	220	—
Self-care - some problem	1	—
Self-care - extreme problem	0	—
Self-care - ambiguous	0	—
Self-care - missing	3	—
Usual activities - no problems	219	—
Usual activities - some problems	2	—
Usual activities - extreme problems	0	—
Usual activities - ambiguous	0	—
Usual activities - missing	3	—
Pain/Discomfort - no problems	192	—
Pain/Discomfort - some problems	28	—
Pain/Discomfort - extreme problems	0	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing	3	—
Anxiety/Depression - no problems	214	—
Anxiety/Depression - some problems	7	—
Anxiety/Depression - extreme problems	0	—
Anxiety/Depression - ambiguous	0	—
Anxiety/Depression - missing	3	—
GlimepirideMobility - no problem	224	—
Mobility - some problem	6	—
Mobility - extreme problem	0	—
Mobility - ambiguous	0	—
Mobility - missing	1	—
Self-care - no problem	228	—
Self-care - some problem	2	—
Self-care - extreme problem	0	—
Self-care - ambiguous	0	—
Self-care - missing	1	—
Usual activities - no problems	228	—
Usual activities - some problems	2	—
Usual activities - extreme problems	0	—
Usual activities - ambiguous	0	—
Usual activities - missing	1	—
Pain/Discomfort - no problems	200	—
Pain/Discomfort - some problems	29	—
Pain/Discomfort - extreme problems	0	—
Pain/Discomfort - ambiguous	0	—
Pain/Discomfort - missing	1	—
Anxiety/Depression - no problems	213	—
Anxiety/Depression - some problems	17	—
Anxiety/Depression - extreme problems	0	—
Anxiety/Depression - ambiguous	0	—
Anxiety/Depression - missing	1	—

Secondary/registry result

Visual Analog Scale (VAS) Score at 26 Weeks

Time frame:Week 26

EQ-5D VAS

descriptive, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
1.5 mg Dulaglutide	85.72	—
0.75 mg Dulaglutide	86.17	—
Glimepiride	85.96	—

Secondary/protocol endpoint

European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks

Time frame:Week 26

EQ-5D index

descriptive

Secondary/protocol endpoint

Visual Analog Scale (VAS) Score at 26 Weeks

Time frame:Week 26

EQ-5D VAS

descriptive, improvement

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Rate of Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), episodes/participant/30 days	95% CI
1.5 mg DulaglutideAll Hypoglycemic Episodes	0.01	—
Severe Hypoglycemic Episodes	NA	—
Nocturnal Hypoglycemic Episodes	0.00	—
0.75 mg DulaglutideAll Hypoglycemic Episodes	0.01	—
Severe Hypoglycemic Episodes	NA	—
Nocturnal Hypoglycemic Episodes	0.00	—
GlimepirideAll Hypoglycemic Episodes	0.09	—
Severe Hypoglycemic Episodes	NA	—
Nocturnal Hypoglycemic Episodes	0.01	—

p<0.001Negative binomial regression model

p0.008Negative binomial regression model

p0.006Negative binomial regression model

Secondary/registry result

Number of Participants With Self-Reported Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg Dulaglutide	14	—
0.75 mg Dulaglutide	9	—
Glimepiride	38	—

p<0.001Fisher Exact

Secondary/registry result

Change From Baseline in Pancreatic Enzymes at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

Posted result

Group	Value (mean), units per liter (u/L)	95% CI
1.5 mg DulaglutideTotal amylase	9.29	—
Pancreas-derived amylase	6.19	—
Lipase	10.62	—
0.75 mg DulaglutideTotal amylase	7.04	—
Pancreas-derived amylase	4.92	—
Lipase	9.28	—
GlimepirideTotal amylase	3.79	—
Pancreas-derived amylase	2.64	—
Lipase	2.38	—

Secondary/registry result

Change From Baseline in Serum Calcitonin at 26 Weeks

Time frame:Baseline, 26 Weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picomoles per liter (pmol/L)	95% CI
1.5 mg Dulaglutide	-0.01	—
0.75 mg Dulaglutide	-0.02	—
Glimepiride	0.02	—

Secondary/registry result

Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

componentsqtcF interval change, pr interval change

Posted result

Group	Value (mean), milliseconds (msec)	95% CI
1.5 mg DulaglutideQT interval	-6.18	—
PR interval	3.73	—
0.75 mg DulaglutideQT interval	-2.06	—
PR interval	3.29	—
GlimepirideQT interval	1.21	—
PR interval	-0.23	—

Secondary/registry result

Percentage of Participants Developing Antibodies to Dulaglutide

Time frame:Baseline through 26 Weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg Dulaglutide	17	—
0.75 mg Dulaglutide	8	—
Glimepiride	4	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis

Time frame:Baseline through 26 Weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg Dulaglutide	7	—
0.75 mg Dulaglutide	5	—
Glimepiride	1	—

Secondary/protocol endpoint

Rate of Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Self-Reported Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change From Baseline in Pancreatic Enzymes at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Serum Calcitonin at 26 Weeks

Time frame:Baseline, 26 Weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Percentage of Participants Developing Antibodies to Dulaglutide

Time frame:Baseline through 26 Weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis

Time frame:Baseline through 26 Weeks

Pancreatitis

event count, event

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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
Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 May (month)PMID32219675doi:10.1007/s13300-020-00799-wvia 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 monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.
Journal of diabetes investigation2020 Jan (month)PMID31102326doi:10.1111/jdi.13075via pubmed nct search
A Randomized Study to Compare the Effects of Once-Weekly Dulaglutide Injection and Once-Daily Glimepiride on Glucose Fluctuation of Type 2 Diabetes Mellitus Patients: A 26-Week Follow-Up.
Journal of diabetes research2019 (year)PMID31183384doi:10.1155/2019/6423987via 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.