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

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05659537

18550

H9X-IN-GBGR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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212 participants in 1 patient group

Dulaglutide

Experimental group

Description:

* 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.

Treatment:

Drug: Dulaglutide