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.
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.
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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Adult Type 2 Diabetes Resources
