DelfaGLP-1 Atlas

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CompletedPhase 4Results posted

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

7

Recruiting sites

—

Enrollment

212

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥23

Primary endpoints

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint))•Documented hypoglycemia•Serious AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

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 IDNCT05659537
Org study ID18550
Secondary IDH9X-IN-GBGREli Lilly and Company

Timeline

Milestones

Study first posted2022-12-21actual
Study start2022-12-29actual
Primary completion2024-01-16actual
Study completion2024-01-16actual
Results first posted2025-02-05actual
Last update posted2025-02-20actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening
•Have hemoglobin A1c (HbA1c) greater than or equal to (≥) 7.5 percent (%) and less than or equal to (≤) 11.5%, both inclusive, at screening
•Have body mass index (BMI) ≥ 23 kilogram/square meter (kg/m²)

Exclusion criteria

•A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM
•Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening or estimated glomerular filtration rate (eGFR) <15 milliliter/minute (ml/min)/1.73 square meter (m²)
•Participants have known hypersensitivity or allergy to dulaglutide or its excipients
•Participants are on systemic steroids for any period of more than 14 days
•Participants have severe gastrointestinal (GI) disease, including severe gastroparesis
•Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma

Endpoints (10)

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

Safety / tolerability / PK
8
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Secondary/registry result

Mean Change in HbA1c From Baseline to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c95% CI
Dulaglutide-1.41—
Secondary/protocol endpoint

Mean Change in HbA1c From Baseline to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

8 endpoints
Primary/registry result

Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths

Time frame:Baseline through Follow-up (up to 28 weeks)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Posted result

GroupValue (count_of_participants), Participants95% CI
DulaglutideTEAEs106—
SAEs1—
Deaths0—
Primary/registry result

Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.

Time frame:Baseline through Follow-up (up to 28 weeks)

Documented hypoglycemia

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Dulaglutide13—
Primary/registry result

Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24

Time frame:Baseline through Week 24

Serious AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

GroupValue (number), percentage of participants95% CI
DulaglutideAEs51.9—
SAEs0.5—
Primary/registry result

Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24

Time frame:Baseline through Week 24

Nausea

event count, event

componentsNausea, Vomiting, Diarrhea

Posted result

GroupValue (count_of_participants), Participants95% CI
Dulaglutide48—
Primary/protocol endpoint

Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths

Time frame:Baseline through Follow-up (up to 28 weeks)

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Primary/protocol endpoint

Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.

Time frame:Baseline through Follow-up (up to 28 weeks)

Documented hypoglycemia

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24

Time frame:Baseline through Week 24

Serious AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24

Time frame:Baseline through Week 24

Nausea

event count, event

componentsNausea, Vomiting, Diarrhea

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.