Effects of mulberry twig alkaloids and canagliflozin in inadequately controlled type 2 diabetes: a randomized controlled study based on flash glucose monitoring

Herbal medicines hold therapeutic potential for diabetes management. This study compared the efficacy and safety of mulberry twig alkaloids (SZ-A) versus canagliflozin administration in poorly oral-antidiabetic controlled patients with type 2 diabetes mellitus (T2DM) by using the flash glucose monitoring (FGM) system. Sixty poorly controlled diabetic patients were randomly assigned to two groups: SZ-A group (n = 30) and canagliflozin group (n = 30). All patients received add-on therapy either SZ-A or canagliflozin treatment for 12 weeks. FGM was applied for 7 days before the start of treatment (baseline) and for 7 days during the final week (week 12) of the 12-week treatment period. General clinical data were collected and analyzed. After 12 weeks of treatment, both SZ-A and canagliflozin significantly reduced HbA1c, fasting and postprandial glucose, 24 h mean blood glucose, and time above range (TAR). Time in range (TIR) was comparable between SZ-A (72.08%) and canagliflozin (73.85%), with no increase in time below range (TBR). In contrast to canagliflozin, SZ-A significantly reduced postprandial glucose excursion (PPGE) after breakfast and dinner. Both SZ-A and canagliflozin also improved insulin resistance and enhanced insulin sensitivity in patients. Additionally, both treatments significantly improved metabolism parameters, including weight, waist circumference, and triglyceride. SZ-A showed hypoglycemic and metabolic effects comparable to canagliflozin, with superior control of postprandial glucose excursion after breakfast and dinner. Clinical trial registration www.clinicaltrials.gov identifier is NCT05856578 (Registered 15 March 2022).