Completed
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.
Completed
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.
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
Adult Type 2 Diabetes
What the trial is testing?
Tirzepatide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
472
Trial Dates
August 2019 - January 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
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
Adult Type 2 Diabetes
What the trial is testing?
Tirzepatide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
472
Trial Dates
August 2019 - January 2021
Trial Phase
3
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