A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Key facts

Study ID

NCT03987919

Run by

Eli Lilly and Company

People needed

1879

Starts

2019-07-30

Expected to finish

2021-02-15

Last updated by the study team

2022-02-14

Who can join

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

You may qualify if…

• 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 >1500 mg/day for at least 3 months prior to screening
• Be of stable weight (±5%) for at least 3 months before screening
• Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

You may not qualify if…

• 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 milliliters/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 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

• Syed Research Consultants Llc — Sheffield, Alabama, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• National Research Institute - Huntington Park — Panorama City, California, United States
• Artemis Institute for Clinical Research — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• CMR of Greater New Haven — Hamden, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• East Coast Institute for Research at The Jones Center — Lake City, Florida, United States
• South Florida Clinical Research Institute — Margate, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Oviedo Medical Research — Oviedo, Florida, United States
• South Broward Research — Pembroke Pines, Florida, United States
• United Osteoporosis Center — Gainesville, Georgia, United States
• Sky Clinical Research Network — Union City, Georgia, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• University of Iowa Hospital & Clinic — Iowa City, Iowa, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• Cahaba Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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