A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

• Status: Active, not recruiting
• Trial end date: 2022-11-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; LY3298176; Tirzepatide

Criteria

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes mellitus (T2DM)

• Have HbA1c between ≥7.5% and ≤11%

• Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors

• Be of stable weight (± 5%) for at least 90 days

• Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 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 macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment

• Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility

• 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

• 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)]