Completed

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

I8F-JE-GPGP - ClinicalTrials.gov - NCT03861039

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.
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.
Email
Completed

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

I8F-JE-GPGP - ClinicalTrials.gov - NCT03861039

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.
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.
Email

Key Requirements

Age :

20+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

20+

Sex

All

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

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide

Could I receive a Placebo?

no

Enrollment Goal

441

Trial Dates

March 2019 - February 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

20+

Sex

All

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

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide

Could I receive a Placebo?

no

Enrollment Goal

441

Trial Dates

March 2019 - February 2021

Trial Phase

3

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Trial Locations

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Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?