A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.
Subject is between 18-75 years of age
Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®)
Body mass index (BMI) is ≥ 25 kg/m2
Subject has type 1 diabetes mellitus
Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
History of acute kidney injury (AKI) during the 6 months prior to screening g.
Parallel
protein supplement
Dietary supplementHP-DSF shakes provided by Abbott Nutrition
Change in lean muscle mass from baseline
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Joslin Diabetes Center
Lead sponsor
Abbott
Collaborator
