CompletedPhase 2Results posted

A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

145

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≥18.5•HbA1c 7-9.5%

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 IDNCT01001104

Org study ID12840

Secondary IDH9X-JE-GBCZEli Lilly and Company

Timeline

Milestones

Study first posted2009-10-23estimated

Last update posted2015-09-28estimated

Results first posted2015-09-28estimated

Study start2009-10 (month precision)

Primary completion2010-12actual (month precision)

Study completion2010-12actual (month precision)

Assets

Investigational agents

Dulaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m^2) but <40.0 kg/m^2.

•Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.

•Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.

•Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.

Exclusion criteria

•Patients who are currently taking prescription medications to promote weight loss

•Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.

•Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.

•Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.

•Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.

•Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.

Endpoints (20)

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

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Total Body Weight at 12 Weeks

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kilograms (kg)	95% CI
0.75 mg LY2189265	-0.58	-1.21 - 0.05
0.5 mg LY2189265	-0.40	-1.01 - 0.22
0.25 mg LY2189265	0.41	-0.20 - 1.03
Placebo	-0.84	-1.46 - -0.22

p0.987Mixed Models Analysis

Least squares mean difference1.26p0.005Mixed Models Analysis

Least squares mean difference0.45p0.311Mixed Models Analysis

Least squares mean difference0.26p0.556Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Total Body Weight at 12 Weeks

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Time frame:Baseline, 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · percentage glycosylated hemoglobin	95% CI
0.75 mg LY2189265	-1.35	-1.53 - -1.18
0.5 mg LY2189265	-1.15	-1.32 - -0.98
0.25 mg LY2189265	-0.90	-1.07 - -0.73
Placebo	-0.18	-0.36 - -0.01

p<.001Mixed Models Analysis

Least squares mean difference-0.72p<0.001Mixed Models Analysis

Least squares mean difference-0.97p<0.001Mixed Models Analysis

Least squares mean difference-1.17p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Time frame:Baseline, 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks

Time frame:up to 12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
0.75 mg LY2189265	77.1	-
0.5 mg LY2189265	59.5	-
0.25 mg LY2189265	47.2	-
Placebo	10.8	-

p<0.001Cochran-Armitage

p<0.001Fisher Exact

Secondary/registry result

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks

Time frame:up to 12 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
0.75 mg LY2189265	34.3	-
0.5 mg LY2189265	24.3	-
0.25 mg LY2189265	8.3	-
Placebo	2.7	-

p<0.001Cochran-Armitage

p0.358Fisher Exact

p0.014Fisher Exact

p<0.001Fisher Exact

Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks

Time frame:Baseline, 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · milligrams per deciliter (mg/dL)	95% CI
0.75 mg LY2189265	-37.48	-47.00 - -27.97
0.5 mg LY2189265	-28.55	-37.68 - -19.41
0.25 mg LY2189265	-29.21	-38.45 - -19.97
Placebo	-9.00	-18.39 - 0.38

p<0.001Mixed Models Analysis

Least squares mean difference-20.20p0.003Mixed Models Analysis

Least squares mean difference-19.54p0.003Mixed Models Analysis

Least squares mean difference-28.48p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks

Time frame:Baseline, 12 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · milligrams per deciliter (mg/dL)	95% CI
0.75 mg LY2189265	-48.99	-58.47 - -39.51
0.5 mg LY2189265	-53.12	-61.84 - -44.41
0.25 mg LY2189265	-40.70	-49.67 - -31.73
Placebo	-7.49	-17.44 - 2.45

p<0.001Mixed Models Analysis

Least squares mean difference-33.20p<0.001Mixed Models Analysis

Least squares mean difference-45.63p<0.001Mixed Models Analysis

Least squares mean difference-41.49p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks

Time frame:Baseline, 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage insulin sensitivity (%S)	95% CI
0.75 mg LY2189265	-4.66	-17.64 - 8.32
0.5 mg LY2189265	-6.07	-18.60 - 6.46
0.25 mg LY2189265	4.65	-7.68 - 16.97
Placebo	3.74	-8.88 - 16.36

p0.202Mixed Models Analysis

Least squares mean difference0.91p0.917Mixed Models Analysis

Least squares mean difference-9.81p0.264Mixed Models Analysis

Least squares mean difference-8.40p0.346Mixed Models Analysis

Secondary/registry result

Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks

Time frame:Baseline, 12 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage beta-cell function	95% CI
0.75 mg LY2189265	38.63	29.36 - 47.90
0.5 mg LY2189265	26.67	17.74 - 35.61
0.25 mg LY2189265	20.04	11.19 - 28.89
Placebo	6.94	-2.10 - 15.98

p<0.001Mixed Models Analysis

Least squares mean difference13.10p0.036Mixed Models Analysis

Least squares mean difference19.73p0.002Mixed Models Analysis

Least squares mean difference31.68p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks

Time frame:up to 12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks

Time frame:up to 12 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks

Time frame:Baseline, 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks

Time frame:Baseline, 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks

Time frame:Baseline, 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks

Time frame:Baseline, 12 weeks

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Steady-State Concentrations of LY2189265

Time frame:12 weeks

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Median · nanograms per milliliter (ng/mL)	95% CI
LY 0.25 mg	15.8	10.4 - 27.0
LY 0.50 mg	28.8	19.2 - 47.4
LY 0.75 mg	42.7	24.3 - 70.0

Secondary/registry result

Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period

Time frame:12 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · percentage of participants	95% CI
0.75 mg LY2189265	5.7	-
0.5 mg LY2189265	2.7	-
0.25 mg LY2189265	0.0	-
Placebo	0.0	-

p0.073Cochran-Armitage

p1.00Fisher Exact

p0.233Fisher Exact

Secondary/protocol endpoint

Steady-State Concentrations of LY2189265

Time frame:12 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period

Time frame:12 weeks

Documented hypoglycemia

threshold achievement, event

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.