DelfaGLP-1 Atlas

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CompletedPhase 4Results posted

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

25

Recruiting sites

—

Enrollment

159

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-35•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 IDNCT02750410
Org study ID15803
Secondary IDH9X-JE-GBGFEli Lilly and Company

Timeline

Milestones

Study first posted2016-04-25estimated
Primary completion2018-06-18actual
Study completion2018-06-18actual
Results first posted2019-09-16actual
Last update posted2019-09-24actual
Study start2016-08 (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
•Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
•Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
•Participants who have stable weight (±5%) ≥3 months prior to 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 received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
•Participants who have been previously treated with dulaglutide prior to screening
•Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
•Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening
•Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities
•Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy

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
10
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilogram (kg)95% CI
Placebo-0.30—
Dulaglutide-0.20—
LS mean difference0.1095% CI-0.59 – 0.78p0.776Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints
Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo0.06—
Dulaglutide-1.45—
LS mean percent difference-1.5095% CI-1.73 – -1.28p<0.001Mixed Models Analysis
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants With HbA1c <7.0% or ≤6.5%

Time frame:Week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo47.4—
Dulaglutide0—
Odds Ratio (OR)0.11795% CI0.028 – 0.479p0.003Regression, Logistic

analysis was based on repeated measures logistic regression

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligram/deciliter (mg/dL)95% CI
Placebo-4.1—
Dulaglutide-34.2—
LS mean difference-30.1495% CI-41.37 – -18.91p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

Time frame:Baseline, Week 16

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
PlaceboPrebreakfast BG12.30—
Breakfast 2-hour PPBG13.15—
Prelunch BG8.08—
Lunch 2-hour PPBG10.74—
Predinner BG5.66—
Dinner 2-hour PPBG3.97—
Bedtime BG13.21—
DulaglutidePrebreakfast BG-14.28—
Breakfast 2-hour PPBG-32.24—
Prelunch BG-28.74—
Lunch 2-hour PPBG-39.42—
Predinner BG-25.61—
Dinner 2-hour PPBG-30.99—
Bedtime BG-28.24—
LS mean difference-26.5995% CI-36.39 – -16.78p<0.001t-test, 2 sided

Prebreakfast BG

LS mean difference-45.3895% CI-61.77 – -29.00p<0.001t-test, 2 sided

Breakfast 2-hour PPBG

LS mean difference-36.8295% CI-49.20 – -24.45p<0.001t-test, 2 sided

Prelunch BG

LS mean difference-50.1695% CI-67.85 – -32.46p<0.001t-test, 2 sided

Lunch 2-hour PPBG

LS mean difference-31.2795% CI-44.05 – -18.48p<0.001t-test, 2 sided

Predinner BG

LS mean difference-34.9795% CI-52.55 – -17.38p<0.001t-test, 2 sided

Dinner 2-hour PPBG

LS mean difference-41.4595% CI-58.81 – -24.09p<0.001t-test, 2 sided

Bedtime BG

Secondary/registry result

Change From Baseline in Daily Total Insulin Dose

Time frame:Baseline, Week 16

change from baseline, improvement

Posted result

GroupValue (mean), International Units (IU)/Day95% CI
Placebo-0.3—
Dulaglutide-1.1—
Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0% or ≤6.5%

Time frame:Week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

Time frame:Baseline, Week 16

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Daily Total Insulin Dose

Time frame:Baseline, Week 16

change from baseline, improvement

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

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.