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 (SURPASS-6)

I8F-MC-GPHD -

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.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Tirzepatide, Insulin Lispro
Could I receive a Placebo?
No
Enrollment Goal
1428
Trial Dates
Oct 19, 2020 - Nov 1, 2022
How long will I be in the trial?
The study will last about 68 weeks and may include up to 24 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:

  • Participants must have type 2 diabetes

  • Participants must have been treated with long acting insulin, once or twice daily with or without metformin, sulfonylureas or dipeptidyl peptidase 4 inhibitors for at least 90 days

  • Participants must have hemoglobin A1c 7.5% and 11.0%

  • Participants must be of stable weight

  • Participants must have a BMI 23 kilograms per meter squared (kg/m2) and 45 kg/m2

Participants Must Not:

  • Participants must not have type 1 diabetes

  • Participants must not have pancreatitis

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

  • Participants must not have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2

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

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Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.