Effect of Retatrutide Compared with Semaglutide in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Metformin with or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Diabetes Mellitus, Type 2The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
* Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
* Are of stable weight for at least 90 days prior to screening
* Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)
Exclusion Criteria:
* Have Type 1 Diabetes (T1D)
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification IV congestive heart failure
* Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
* Have any lifetime history of a suicide attempt
* Had chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
* Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Study Location
Aggarwal and Associates Limited
Aggarwal and Associates LimitedBrampton, Ontario
Canada
Contact Study Team
Naresh Aggarwal
Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.Sarnia, Ontario
Canada
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John O'Mahony
9109-0126 Quebec Inc.
9109-0126 Quebec Inc.Montreal, Quebec
Canada
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Ronald Akhras
Centricity Research Brampton Endocrinology
Centricity Research Brampton EndocrinologyBrampton, Ontario
Canada
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Harpreet Bajaj
Hamilton Medical Research Group
Hamilton Medical Research GroupHamilton, Ontario
Canada
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Richard Tytus
Private Practice - Dr. Nigel Jagan
Private Practice - Dr. Nigel JaganWhitby, Ontario
Canada
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Nigel Jagan
University of Calgary - Clinical Trials Unit
University of Calgary - Clinical Trials UnitCalgary, Alberta
Canada
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Ronald Sigal
Dr. Steven V. Zizzo Research Professional Corporation
Dr. Steven V. Zizzo Research Professional CorporationHamilton, Ontario
Canada
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Steven Zizzo
Prime Health Clinical Research
Prime Health Clinical ResearchToronto, Ontario
Canada
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Iris Shasha Gorfinkel
Alberta Diabetes Institute
Alberta Diabetes InstituteEdmonton, Alberta
Canada
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Peter Senior
The Wharton Medical Clinic Clinical Trials Inc
The Wharton Medical Clinic Clinical Trials IncHamilton, Ontario
Canada
Contact Study Team
Sean Wharton
Maple Leaf Research
Maple Leaf ResearchToronto, Ontario
Canada
Contact Study Team
Graham Smith
- Study Sponsored By
- Eli Lilly and Company
- Participants Required
- More Information
- Study ID:
NCT06260722