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NCT05659537
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 200
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.
Eligibility Criteria
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, andHave 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 T2DMBeen 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.
Source: ClinicalTrials.gov (NCT05659537). StuddyBuddy aggregates publicly available trial information.