A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Insulin Glargine, Tirzepatide
Could I receive a Placebo?
No
Enrollment Goal
2002
Trial Dates
Nov 20, 2018 - Apr 22, 2021
How long will I be in the trial?
The study will last about 108 weeks and may include up to 30 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have type 2 diabetes mellitus (T2DM)

  • Participant must be on stable treatment dose of at least 1 and no more than 3 oral antihyperglycemic drugs

  • Participant must have increased risk for cardiovascular events

  • Participant must be of stable weight

Participants Must Not:

  • Participant must not have type 1 diabetes mellitus (T1DM)

  • Participant must not have pancreatitis

  • Participant must not have disorders with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss

  • Participant must not have acute or chronic hepatitis or symptoms of any other liver disease

  • Participant must not have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months

  • Participant must not have been taking weight loss drugs including over-the-counter medications during the last 3 months

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