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

Sponsor
Eli Lilly and Company
Study ID
NCT05659537
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.

Key Dates

Start date
Dec 29, 2022
Status verified
Feb 2025
Primary completion
Jan 16, 2024
Completion
Jan 16, 2024

Study Design

Enrollment
212 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dulaglutide
    * Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.

Primary Outcome Measure

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) ]

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