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

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03882970

Run by

Eli Lilly and Company

People needed

1444

Starts

2019-04-01

Expected to finish

2021-01-04

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 their 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

Where it is running

• Valley Research — Fresno, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• National Research Institute — Panorama City, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Indago Research & Health Center, Inc. — Hialeah, Florida, United States
• East Coast Clinical Research — Jacksonville, Florida, United States
• East Coast Institute For Research — Jacksonville, Florida, United States
• Bayside Clinical Research, LLC — New Port Richey, Florida, United States
• East Coast Institute For Research — Macon, Georgia, United States
• Sky Clinical Research Network — Union City, Georgia, United States
• Elite Clinical Trials LLLP — Blackfoot, Idaho, United States
• Humphreys Diabetes Center — Boise, Idaho, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Springfield Diabetes & Endocrine Center — Springfield, Illinois, United States
• Crescent City Clinical Research — Metairie, Louisiana, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Troy Internal Medicine, PC — Troy, Michigan, United States
• International Diabetes Center — Minneapolis, Minnesota, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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