2.2. Study Endpoints
hypoglycemia
ADVERSE EVENTS, HYPOGLYCEMIA, SECONDARY, INSULIN RESISTANCE, HYPOGLYCEMIC EPISODES
The primary endpoint was the change in the gut microbiota (Firmicutes/Bacteroidetes ratio) after 24 weeks of treatment. Detailed analyses were conducted at the genus and species levels. The secondary endpoint was the change in HbA1c levels from the baseline to the 24-week time point. The exploratory endpoints were changes in the levels of circulatory amino acids—surrogate markers for pancreatic β-cell function and insulin resistance—and body composition. For safety assessment, adverse events including hypoglycemia were assessed during the study period. Hypoglycemic episodes were determined based on participants’ symptoms reflecting hypoglycemia and a self-monitored plasma glucose level <70 mg/dL.