GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT03315780

CompletedPhase 4Results posted

A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Postprandial glucose

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 IDNCT03315780

Org study ID16730

Secondary IDH9X-JE-GBGKEli Lilly and Company

Timeline

Milestones

Study first posted2017-10-20actual

Study start2017-10-28actual

Primary completion2018-02-28actual

Study completion2018-02-28actual

Results first posted2019-04-30actual

Last update posted2019-09-16actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year.

•Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).

•Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.

•Have a screening body weight of ≥50 and ≤80 kilograms.

Exclusion criteria

•Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.

•Have had a clinically significant cardiovascular disease.

•Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease.

•Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.

•Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared.

•In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

Endpoints (16)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

11 endpoints

Primary/registry result

Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])

Time frame:Baseline, 4 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligramhour per deciliter (mgh/dL)	95% CI
Dulaglutide	-238.46	-293.87 – -183.05
Placebo	15.56	-71.27 – 102.39

Mean Difference (Final Values)-254.0295% CI-337.76 – -170.28p< 0.0001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])

Time frame:Baseline, 4 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/registry result

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 4 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), milligrams per deciliter (mg/dL)	95% CI
Dulaglutide	-39.8	—
Placebo	-8.2	—

Secondary/registry result

Change From Baseline in Postprandial Blood Glucose

Time frame:Baseline, 4 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Dulaglutide	-67.0	—
Placebo	13.9	—

Secondary/registry result

Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), insulin unitsh/mL (µUh/mL)	95% CI
Dulaglutide	25.20	7.29 – 43.10
Placebo	-2.27	-11.39 – 6.85

Mean Difference (Final Values)27.4695% CI8.05 – 46.87p0.0100Mixed Models Analysis

Secondary/registry result

Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), nanogramh/milliliter (ngh/mL)	95% CI
Dulaglutide	3.58	0.44 – 6.72
Placebo	-0.14	-1.24 – 0.96

Mean Difference (Final Values)3.7295% CI0.63 – 6.81p0.0263Mixed Models Analysis

Secondary/registry result/low confidence

Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomoleh/Liter (pmolh/L)	95% CI
Dulaglutide	-16.39	-25.69 – -7.09
Placebo	-7.02	-12.81 – -1.24

Mean Difference (Final Values)-9.3695% CI-20.16 – 1.43p0.0800Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 4 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Postprandial Blood Glucose

Time frame:Baseline, 4 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mg*h/dL	95% CI
Dulaglutide	31.02	-54.70 – 116.74
Placebo	46.41	-76.55 – 169.38

Mean Difference (Final Values)-15.3995% CI-118.35 – 87.57p0.7475Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Participants Who Develop Hypoglycemic Events

Time frame:Baseline through 4 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Dulaglutide	0	—
Placebo	0	—

Secondary/protocol endpoint

Number of Participants Who Develop Hypoglycemic Events

Time frame:Baseline through 4 weeks

Documented hypoglycemia

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Time frame:Baseline, 4 Weeks

change from baseline, improvement

Publications (1)

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

Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial.
Diabetes therapy : research, treatment and education of diabetes and related disorders2019 Jun (month)PMID30949907doi:10.1007/s13300-019-0605-7via 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.