GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

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

A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

361

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-35•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 IDNCT01584232

Org study ID14359

Secondary IDH9X-JE-GBDYEli Lilly and Company

Timeline

Milestones

Study first posted2012-04-24estimated

Last update posted2014-10-20estimated

Results first posted2014-10-20estimated

Study start2012-04 (month precision)

Primary completion2013-07actual (month precision)

Study completion2013-07actual (month precision)

Assets

Investigational agents

Dulaglutide

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 for at least 6 months before screening

•Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable

•Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening

•Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (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 received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening

•Participants who have been currently taking insulin or have had previous insulin 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 (12)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 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), kilograms (kg)	95% CI
LY2189265 + OAM	-0.48	—
Insulin Glargine + OAM	0.94	—

LS Mean Difference-1.4295% CI-1.89 – -0.94p<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

Glycemic / diabetes

8 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 + OAM	-1.44	—
Insulin Glargine + OAM	-0.90	—

LS Mean Difference-0.5495% CI-0.67 – -0.41p<0.001Mixed 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

Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks

Time frame:Up to 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265 + OAMHbA1c <=6.5%	51.1	—
HbA1c <7%	71.3	—
Insulin Glargine + OAMHbA1c <=6.5%	24.0	—
HbA1c <7%	45.8	—

p<0.001Regression, Logistic

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), milligrams per deciliter (mg/dL)	95% CI
LY2189265 + OAM	-34.3	—
Insulin Glargine + OAM	-37.8	—

LS Mean Difference3.595% CI-1.7 – 8.7p0.183Mixed Models Analysis

Secondary/registry result

Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks

Time frame:Baseline, Up to 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
LY2189265 + OAMPre-morning meal (n=178, 179)	-33.49	—
2 hours post-morning meal (n=178, 179)	-49.54	—
Pre-midday meal (n=178, 179)	-36.16	—
2 hours post-midday meal (n=178, 179)	-43.51	—
Pre-evening meal (n=178, 179)	-31.14	—
2 hours post-evening meal (n=177, 178)	-46.68	—
Bedtime (n=177, 172)	-41.53	—
Second pre-morning meal (n=178, 179)	-30.81	—
Insulin Glargine + OAMPre-morning meal (n=178, 179)	-38.66	—
2 hours post-morning meal (n=178, 179)	-36.14	—
Pre-midday meal (n=178, 179)	-27.94	—
2 hours post-midday meal (n=178, 179)	-20.30	—
Pre-evening meal (n=178, 179)	-17.50	—
2 hours post-evening meal (n=177, 178)	-15.55	—
Bedtime (n=177, 172)	-17.79	—
Second pre-morning meal (n=178, 179)	-37.02	—

LS Mean Difference5.1695% CI0.76 – 9.56p0.022ANCOVA

LS Mean Difference-13.4095% CI-22.28 – -4.52p0.003ANCOVA

LS Mean Difference-8.2295% CI-15.37 – -1.06p0.025ANCOVA

LS Mean Difference-23.2295% CI-31.92 – -14.51p<0.001ANCOVA

LS Mean Difference-13.6395% CI-21.03 – -6.24p<0.001ANCOVA

LS Mean Difference-31.1395% CI-39.26 – -23.00p<0.001ANCOVA

LS Mean Difference-23.7395% CI-31.68 – -15.79p<0.001ANCOVA

LS Mean Difference6.2195% CI1.92 – 10.50p0.005ANCOVA

Secondary/protocol endpoint

Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks

Time frame:Up to 26 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

Time frame:Baseline, 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks

Time frame:Baseline, Up to 26 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Percentage of Participants With Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265 + OAM	26.0	—
Insulin Glargine + OAM	47.8	—

p<0.001Fisher Exact

Secondary/protocol endpoint

Percentage of Participants With Hypoglycemic Episodes

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

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

The cost-effectiveness of dulaglutide versus insulin glargine for the treatment of type 2 diabetes mellitus in Japan.
Journal of medical economics2018 May (month)PMID29357718doi:10.1080/13696998.2018.1431918via 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.