Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadeq… (NCT06354660) | Clinical Trial Compass
CompletedPhase 3
Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
United States537 participantsStarted 2024-04-10
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 inadequate glycemic control. The study will last about 11 months and may include up to 11 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% to ≤ 9.5%
* Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
* 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/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) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) 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 histo…
What they're measuring
1
Change from Baseline in Hemoglobin A1c (HbA1c) (%)