Study S002004

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05659537
Study type: INTERVENTIONAL
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 212
Start: 2022-12-29
Primary completion: 2024-01-16
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Dulaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-IN-GBGR

Registered primary outcomes

Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths [Baseline through Follow-up (up to 28 weeks)]
Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events. [Baseline through Follow-up (up to 28 weeks)]
Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 [Baseline through Week 24]
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24 [Baseline through Week 24]

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