A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Launched by ELI LILLY AND COMPANY · Jul 30, 2019

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Eligibility criteria

• Inclusion Criteria:
• • Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
• • Have HbA1c between ≥7.0% and ≤10.5%.
• • Have a stable weight (± 5%) for at least 3 months before screening.
• • Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.
• Exclusion Criteria:
• • Have type 1 diabetes mellitus.
• • Have had chronic or acute pancreatitis any time prior to study entry.
• • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
• • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
• • Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
• • Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
• • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
• • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.