Outcomes
retinopathy, nephropathy
RETINOPATHY, ADVERSE EVENTS, HYPOGLYCEMIA, SECONDARY, NEPHROPATHY, PERIPHERAL NEUROPATHY
The primary efficacy outcomes were changes in glycemic parameters, including fasting plasma glucose (FPG), HbA1c, and glycated albumin (GA) levels, and the secondary outcomes were changes in body weight, body mass index (BMI), and insulin-related parameters (fasting insulin and proinsulin). Potential improvements (or suppression of deterioration) in nephropathy (serum Cr and cystatin C [CysC], Cr- and CysC-based eGFR, urinary albumin-Cr ratio [uACR]), retinopathy (ophthalmofundoscopic findings), and peripheral neuropathy (Achilles tendon reflex test) were also assessed as efficacy outcomes. Safety was assessed with respect to reported episodes of hypoglycemia, other adverse events, and laboratory measurements including hematology and serum liver enzyme levels.