A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

• Status: Completed
• Trial end date: 2021-01-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Tirzepatide

Criteria

Inclusion Criteria:

• Participants must:

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

• Have HbA1c between ≥7.0% and ≤10.5%

• Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening

• Be of stable weight (± 5%) for at least 3 months before screening

• Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

• Participants must not:

• 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 acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range

• Have an estimated glomerular filtration rate <45 mL/minute/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 any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months

• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months