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

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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Dulaglutide


Participation Criteria
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Eligibility Criteria
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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 HbA1c ≥7.5% and ≤11.5%, both inclusive, at screening, and 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dulaglutide<br>Participants will receive dulaglutide subcutaneously (SC) | Drug: Dulaglutide<br>* Administered SC<br>* Other names: LY2189265;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Gastrointestinal (GI) Adverse Events |  | Baseline up to Week 24 | 
| Incidence of Death, Serious Adverse Event(s), AEs and Treatment Emergent Adverse Events (TEAEs) |  | Baseline up to Week 24 | 
| Incidence of Hypoglycemia including Severe Hypoglycemia |  | Baseline up to Week 24 | 
| Percentage of Participants with AEs and SAEs |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Hemoglobin A1c (HbA1c) |  | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, GLP-1