Recruiting

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

I8F-MC-GPGN - ClinicalTrials.gov - NCT04255433

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
How long will I be in the trial?
The study will last about 54 months and may include up to 35 visits.
Email
Recruiting

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

I8F-MC-GPGN - ClinicalTrials.gov - NCT04255433

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
How long will I be in the trial?
The study will last about 54 months and may include up to 35 visits.
Email

Key Requirements

Age :

40+

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

40+

Sex

All

Participants must

Participants must have a diagnosis of type 2 diabetes

Participants must have confirmed cardiovascular disease

Participants must have HbA1c ≥7.0% to ≤10.5%

Participants must have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Participants must NOT

Participants must not have had a major cardiovascular event within the last 60 days

Participants must not have type 1 diabetes mellitus

Participants must not have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months

Participants must not have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment

Participants must not be currently planning a coronary, carotid, or peripheral artery revascularization

Participants must not have a history of pancreatitis

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Dulaglutide

Could I receive a Placebo?

no

Enrollment Goal

12500

Trial Dates

May 2020 - October 2024

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

40+

Sex

All

Participants must

Participants must have a diagnosis of type 2 diabetes

Participants must have confirmed cardiovascular disease

Participants must have HbA1c ≥7.0% to ≤10.5%

Participants must have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Participants must NOT

Participants must not have had a major cardiovascular event within the last 60 days

Participants must not have type 1 diabetes mellitus

Participants must not have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months

Participants must not have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment

Participants must not be currently planning a coronary, carotid, or peripheral artery revascularization

Participants must not have a history of pancreatitis

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Dulaglutide

Could I receive a Placebo?

no

Enrollment Goal

12500

Trial Dates

May 2020 - October 2024

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?