Recruiting

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 - ClinicalTrials.gov - NCT04537923

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.
How long will I be in the trial?
The study will last about 68 weeks and may include up to 24 visits.
Email
Recruiting

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 - ClinicalTrials.gov - NCT04537923

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.
How long will I be in the trial?
The study will last about 68 weeks and may include up to 24 visits.
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 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

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Insulin Lispro

Could I receive a Placebo?

no

Enrollment Goal

1182

Trial Dates

October 2020 - September 2022

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

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Insulin Lispro

Could I receive a Placebo?

no

Enrollment Goal

1182

Trial Dates

October 2020 - September 2022

Trial Phase

3

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Trial Locations

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Adult 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?