GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01558271

CompletedPhase 3Results posted

A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

492

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT01558271

Org study ID13990

Secondary IDH9X-JE-GBDPEli Lilly and Company

Timeline

Milestones

Study first posted2012-03-20estimated

Results first posted2014-10-30estimated

Last update posted2015-05-22estimated

Study start2012-03 (month precision)

Primary completion2013-10actual (month precision)

Study completion2014-05actual (month precision)

Assets

Investigational agents

Dulaglutide Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants who have had a diagnosis of type 2 diabetes mellitus before screening.

•Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.

•Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.

•Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m^2) to 35.0 kg/m^2.

Exclusion criteria

•Participants who have a diagnosis of type 1 diabetes.

•Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog.

•Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening.

•Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 3 months before screening.

•Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening.

•Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC).

Endpoints (38)

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

Cardiovascular outcomes

Weight & body composition

Cardiovascular outcomes

2 endpoints

Secondary/registry result

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

Time frame:Baseline through 26 weeks and 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	Value (number), participants	95% CI
LY218926526 weeks	0	—
52 weeks	0	—
Placebo/LY218926526 weeks	0	—
52 weeks	0	—
Liraglutide26 weeks	0	—
52 weeks	0	—

Secondary/protocol endpoint

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

Time frame:Baseline through 26 weeks and 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

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
LY218926526 weeks	-0.02	—
52 weeks	-0.17	—
Placebo/LY218926526 weeks	-0.63	—
52 weeks	-1.03	—
Liraglutide26 weeks	-0.36	—
52 weeks	-0.13	—

LS Mean Difference0.6195% CI-0.02 – 1.23p0.057Mixed Models Analysis

LS Mean Difference0.3495% CI-0.14 – 0.82p0.168Mixed Models Analysis

LS Mean Difference-0.0395% CI-0.64 – 0.57p0.911Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

16 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
LY2189265	-1.43	—
Placebo	0.14	—
Liraglutide	-1.33	—

LS Mean Difference-1.5795% CI-1.79 – -1.35p<0.001Mixed Models Analysis

LS Mean Difference-0.1095% CI-0.27 – 0.07p0.248Mixed Models Analysis

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 Glycosylated Hemoglobin (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
LY2189265	-1.39	—
Placebo/LY2189265	-1.55	—
Liraglutide	-1.19	—

LS Mean Difference-0.2095% CI-0.39 – -0.01p0.040Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieved HbA1c <=6.5% or <7%

Time frame:Up to 26 and 52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265HbA1c <7%, 26 weeks	71.4	—
HbA1c <=6.5%, 26 weeks	50.0	—
HbA1c <7%, 52 weeks	67.9	—
HbA1c <=6.5%, 52 weeks	49.3	—
Placebo/LY2189265HbA1c <7%, 26 weeks	5.9	—
HbA1c <=6.5%, 26 weeks	1.5	—
HbA1c <7%, 52 weeks	70.6	—
HbA1c <=6.5%, 52 weeks	52.9	—
LiraglutideHbA1c <7%, 26 weeks	69.1	—
HbA1c <=6.5%, 26 weeks	49.3	—
HbA1c <7%, 52 weeks	60.3	—
HbA1c <=6.5%, 52 weeks	41.2	—

p<0.001Cochran-Mantel-Haenszel

p0.608Cochran-Mantel-Haenszel

p<0.001Cochran-Mantel-Haenszel

p0.844Cochran-Mantel-Haenszel

p0.112Cochran-Mantel-Haenszel

p0.103Cochran-Mantel-Haenszel

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), milligrams per deciliter (mg/dL)	95% CI
LY218926526 weeks	-39.18	—
52 weeks	-38.93	—
Placebo/LY218926526 weeks	1.03	—
52 weeks	-40.93	—
Liraglutide26 weeks	-39.75	—
52 weeks	-37.15	—

LS Mean Difference-40.2195% CI-47.31 – -33.11p<0.001Mixed Models Analysis

LS Mean Difference0.5795% CI-4.82 – 5.96p0.835Mixed Models Analysis

LS Mean Difference-1.7795% CI-7.65 – 4.10p0.553Mixed Models Analysis

Secondary/registry result

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
LY2189265Pre-morning meal, 26 weeks	-39.65	—
2 hours post-morning meal, 26 weeks	-69.64	—
Pre-midday meal, 26 weeks	-48.47	—
2 hours post-midday meal, 26 weeks	-67.57	—
Pre-evening meal, 26 weeks	-39.64	—
2 hours post-evening meal	-56.70	—
Bedtime, 26 weeks	-53.39	—
Pre-morning meal, 52 weeks	-37.46	—
2 hours post-morning meal, 52 weeks	-66.96	—
Pre-midday meal, 52 weeks	-47.03	—
2 hours post-midday meal, 52 weeks	-68.21	—
Pre-evening meal, 52 weeks	-41.04	—
2 hours post-evening meal, 52 weeks	-55.01	—
Bedtime, 52 weeks	-55.76	—
Placebo/LY2189265Pre-morning meal, 26 weeks	-0.15	—
2 hours post-morning meal, 26 weeks	-9.29	—
Pre-midday meal, 26 weeks	3.91	—
2 hours post-midday meal, 26 weeks	-1.50	—
Pre-evening meal, 26 weeks	9.25	—
2 hours post-evening meal	0.93	—
Bedtime, 26 weeks	4.26	—
Pre-morning meal, 52 weeks	-30.12	—
2 hours post-morning meal, 52 weeks	-65.91	—
Pre-midday meal, 52 weeks	-45.15	—
2 hours post-midday meal, 52 weeks	-58.52	—
Pre-evening meal, 52 weeks	-36.13	—
2 hours post-evening meal, 52 weeks	-55.26	—
Bedtime, 52 weeks	-51.19	—
LiraglutidePre-morning meal, 26 weeks	-34.93	—
2 hours post-morning meal, 26 weeks	-61.67	—
Pre-midday meal, 26 weeks	-45.08	—
2 hours post-midday meal, 26 weeks	-66.71	—
Pre-evening meal, 26 weeks	-36.62	—
2 hours post-evening meal	-53.14	—
Bedtime, 26 weeks	-51.07	—
Pre-morning meal, 52 weeks	-33.41	—
2 hours post-morning meal, 52 weeks	-60.69	—
Pre-midday meal, 52 weeks	-46.25	—
2 hours post-midday meal, 52 weeks	-62.57	—
Pre-evening meal, 52 weeks	-32.86	—
2 hours post-evening meal, 52 weeks	-42.30	—
Bedtime, 52 weeks	-49.10	—

Secondary/registry result

Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) 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	95% CI
LY2189265HOMA2-%S based on FI, 26 weeks (n=254, 57, 115)	-4.83	—
HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)	-5.48	—
HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)	-7.75	—
HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)	-11.72	—
Placebo/LY2189265HOMA2-%S based on FI, 26 weeks (n=254, 57, 115)	-2.97	—
HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)	-6.32	—
HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)	NA	—
HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)	NA	—
LiraglutideHOMA2-%S based on FI, 26 weeks (n=254, 57, 115)	-4.82	—
HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)	-2.46	—
HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)	-5.26	—
HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)	-10.68	—

LS Mean Difference-1.8695% CI-12.20 – 8.48p0.723ANCOVA

LS Mean Difference-0.0195% CI-7.92 – 7.91p0.998ANCOVA

LS Mean Difference0.8395% CI-7.72 – 9.38p0.848ANCOVA

LS Mean Difference-3.0395% CI-9.48 – 3.42p0.357ANCOVA

LS Mean Difference-2.4995% CI-10.35 – 5.36p0.533ANCOVA

LS Mean Difference-1.0395% CI-7.32 – 5.25p0.747ANCOVA

Secondary/registry result

Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) 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	95% CI
LY2189265HHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)	28.42	—
HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)	27.77	—
HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)	27.81	—
HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)	29.59	—
Placebo/LY2189265HHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)	0.08	—
HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)	2.94	—
HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)	NA	—
HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)	NA	—
LiraglutideHHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)	25.35	—
HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)	25.86	—
HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)	25.89	—
HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)	28.85	—

LS Mean Difference28.3595% CI21.63 – 35.07p<0.001ANCOVA

LS Mean Difference3.0895% CI-2.09 – 8.24p0.242ANCOVA

LS Mean Difference24.8295% CI19.25 – 30.40p<0.001ANCOVA

LS Mean Difference1.9195% CI-2.32 – 6.13p0.376ANCOVA

LS Mean Difference1.9195% CI-2.72 – 6.54p0.417ANCOVA

LS Mean Difference0.7395% CI-3.83 – 5.29p0.753ANCOVA

Secondary/registry result

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

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

event count, event

Posted result

Group	Value (number), participants	95% CI
LY218926526 weeks	0	—
52 weeks	0	—
Placebo/LY218926526 weeks	0	—
52 weeks	0	—
Liraglutide26 weeks	0	—
52 weeks	0	—

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <=6.5% or <7%

Time frame:Up to 26 and 52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

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) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

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

threshold achievement, event

Cardiometabolic biomarkers

4 endpoints

Secondary/registry result

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

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
LY218926526 weeks	3.35	—
52 weeks	3.11	—
Placebo/LY218926526 weeks	1.49	—
52 weeks	4.42	—
Liraglutide26 weeks	4.77	—
52 weeks	5.13	—

Secondary/registry result

Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliliters of mercury (mmHG)	95% CI
LY2189265SBP, 26 weeks	0.62	—
DBP, 26 weeks	1.09	—
SBP, 52 weeks	1.32	—
DBP, 52 weeks	1.41	—
Placebo/LY2189265SBP, 26 weeks	0.53	—
DBP, 26 weeks	0.29	—
SBP, 52 weeks	0.37	—
DBP, 52 weeks	1.16	—
LiraglutideSBP, 26 weeks	-2.10	—
DBP, 26 weeks	0.43	—
SBP, 52 weeks	-1.86	—
DBP, 52 weeks	1.17	—

Secondary/protocol endpoint

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

Time frame:Baseline, 26 weeks, 52 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Percentage of Participants With Hypoglycemic Episodes

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

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
LY218926526 weeks	2.1	—
52 weeks	2.9	—
Placebo/LY218926526 weeks	1.4	—
52 weeks	2.9	—
Liraglutide26 weeks	1.5	—
52 weeks	2.9	—

p>0.999Fisher Exact

Secondary/registry result

30-Day Rate of Hypoglycemic Episodes

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

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per 30 days	95% CI
LY218926526 weeks	0.01	—
52 weeks	0.00	—
Placebo/LY218926526 weeks	0.00	—
52 weeks	0.01	—
Liraglutide26 weeks	0.00	—
52 weeks	0.01	—

Secondary/registry result

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

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

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
LY218926526 weeks	0	—
52 weeks	0	—
Placebo/LY218926526 weeks	0	—
52 weeks	0	—
Liraglutide26 weeks	0	—
52 weeks	0	—

Secondary/registry result

Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units/liter	95% CI
LY2189265Lipase, 26 weeks	7.0	1.0 – 13.0
Total Amylase, 26 weeks	7.0	2.0 – 15.0
Lipase, 52 weeks	6.0	1.0 – 12.0
Total Amylase, 52 weeks	7.0	1.0 – 14.0
Placebo/LY2189265Lipase, 26 weeks	1.0	-6.0 – 5.0
Total Amylase, 26 weeks	0.0	-6.0 – 6.0
Lipase, 52 weeks	6.0	2.0 – 12.0
Total Amylase, 52 weeks	9.0	3.0 – 14.0
LiraglutideLipase, 26 weeks	11.0	5.0 – 21.0
Total Amylase, 26 weeks	7.0	1.0 – 15.0
Lipase, 52 weeks	9.0	3.0 – 19.0
Total Amylase, 52 weeks	6.0	1.0 – 11.0

Secondary/registry result

Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (median), picograms/milliliter	95% CI
LY218926526 weeks	0.0	0.0 – 0.0
52 weeks	0.0	0.0 – 0.0
Placebo/LY218926526 weeks	0.0	0.0 – 0.0
52 weeks	0.0	0.0 – 0.0
Liraglutide26 weeks	0.0	0.0 – 0.0
52 weeks	0.0	0.0 – 0.0

Secondary/registry result

Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks

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

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
LY218926526 weeks (n=279, 68, 133)	3	—
52 weeks (n=279, 68, 134)	3	—
Placebo/LY218926526 weeks (n=279, 68, 133)	0	—
52 weeks (n=279, 68, 134)	0	—
Liraglutide26 weeks (n=279, 68, 133)	0	—
52 weeks (n=279, 68, 134)	0	—

Secondary/registry result

Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
LY2189265QTcF, 26 weeks (n=273, 64, 128)	-2.02	—
QTcF, 52 weeks (n=274, 64, 128)	-2.76	—
PR, 26 weeks (n=269, 65, 126)	2.20	—
PR, 52 weeks (n=270, 65, 126)	2.81	—
Placebo/LY2189265QTcF, 26 weeks (n=273, 64, 128)	-0.96	—
QTcF, 52 weeks (n=274, 64, 128)	-0.80	—
PR, 26 weeks (n=269, 65, 126)	-0.45	—
PR, 52 weeks (n=270, 65, 126)	2.60	—
LiraglutideQTcF, 26 weeks (n=273, 64, 128)	-1.89	—
QTcF, 52 weeks (n=274, 64, 128)	-4.35	—
PR, 26 weeks (n=269, 65, 126)	2.07	—
PR, 52 weeks (n=270, 65, 126)	3.71	—

Secondary/protocol endpoint

Percentage of Participants With Hypoglycemic Episodes

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

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

30-Day Rate of Hypoglycemic Episodes

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

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

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

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

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks

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

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks

Time frame:Baseline, 26 weeks, 52 weeks

change from baseline, descriptive

Publications (2)

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

Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Feb (month)PMID29264713doi:10.1007/s13300-017-0346-4via clinicaltrials gov reference derived + pubmed nct search
Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.
Health and quality of life outcomes2017 Jun 12PMID28606095doi:10.1186/s12955-017-0696-7via 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.