Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or … (NCT06297603) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
United States320 participantsStarted 2024-03-15
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
* Have moderate or severe renal impairment
* Have been on the following stable diabetes treatment during 90 days prior to screening
* basal insulin (≥20 International Units (IU)/day) with or without
* metformin and/or SGLT2 inhibitor
* Are of stable weight for at least 90 days prior to screening
* Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)
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 a history of unstable or rapidly progressing renal disease
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification III or IV congestive heart failure
* Have had 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 a family or personal history of medullary thyroid carcinoma …
What they're measuring
1
Change from Baseline in Hemoglobin A1c (HbA1c) (%)