Active not recruiting

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

I8F-MC-GPGI - ClinicalTrials.gov - NCT04039503

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications.
How long will I be in the trial?
Your participation could last about 47 weeks and may include up to 23 visits to the study center.
Email
Active not recruiting

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

I8F-MC-GPGI - ClinicalTrials.gov - NCT04039503

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications.
How long will I be in the trial?
Your participation could last about 47 weeks and may include up to 23 visits to the study center.
Email

Key Requirements

Age :

18+

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

18+

Sex

All

Participants must

Participants must have type 2 diabetes

Participants must have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months

Participants must have hemoglobin A1c ≥7.0% and ≤10.5%

Participants must be of stable weight

Participants must have a BMI ≥23 kilograms per meter squared (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

Trial Summary

Conditions the trial is for

Type 2 Diabetes

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

472

Trial Dates

August 2019 - February 2021

Trial Phase

3

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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

18+

Sex

All

Participants must

Participants must have type 2 diabetes

Participants must have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months

Participants must have hemoglobin A1c ≥7.0% and ≤10.5%

Participants must be of stable weight

Participants must have a BMI ≥23 kilograms per meter squared (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

Trial Summary

Conditions the trial is for

Type 2 Diabetes

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

472

Trial Dates

August 2019 - February 2021

Trial Phase

3

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Trial Locations

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Type 2 Diabetes Resources

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?