A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

Trial Summary

Age Range
≥20 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Oral antihyperglycemic medication (OAM), Tirzepatide
Could I receive a Placebo?
No
Enrollment Goal
443
Trial Dates
Mar 30, 2019 - Feb 16, 2021
How long will I be in the trial?
Your participation could last about 60 weeks and may include up to 14 visits to the study center.
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 hemoglobin A1c 7.0% and 11.0%

  • Participants must have been taking certain medications (sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitors) for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening

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

  • Participants must be of stable weight

Participants Must Not:

  • Participants must not have type 1 diabetes

  • Participants must not have inflammation of the pancreas

  • 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 during the last 3 months

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