Status:
COMPLETED
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 metf...
Eligibility Criteria
Inclusion
- Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
- Have HbA1c between ≥7.0% and ≤10.5%.
- Have a stable weight (± 5%) for at least 3 months before screening.
- Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.
Exclusion
- Have type 1 diabetes mellitus.
- Have had chronic or acute pancreatitis any time prior to study entry.
- Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
- Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
- Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
- Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
- Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2021
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT04039503
Start Date
August 30 2019
End Date
January 13 2021
Last Update
January 12 2022
Active Locations (48)
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1
Valley Endocrine, Fresno
Fresno, California, United States, 93720
2
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States, 34652
3
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States, 03063
4
Manhattan Medical Research
New York, New York, United States, 10016