Abstract
INTRODUCTION: There is relatively little data from China on the efficacy and safety of adding prandial insulin to basal insulin plus oral antidiabetic drugs (OADs) in people with poorly controlled type 2 diabetes mellitus (T2DM). This study assessed the efficacy and safety of basal insulin dose optimization followed by the addition of prandial insulin in Chinese people with T2DM achieving suboptimal glycemic control with basal insulin and OADs. METHODS: In this open-label, single-arm study, adults with T2DM receiving basal insulin plus OADs underwent insulin dose optimization for 12 weeks. At week 12, subjects who achieved fasting blood glucose (FBG) ≤6.5 mmol/L but not HbA1c ≤7% added one injection of prandial insulin at the main meal for an additional 24 weeks. Endpoints included mean HbA1c, the achievement rate of HbA1c ≤7%, hypoglycemia, and other adverse events (AEs). RESULTS: A total of 120 subjects underwent basal insulin optimization; At week 12, 110 study subjects achieved FBG ≤6.5 mmol/L, of whom 66 did not achieve HbA1c ≤7% and therefore initiated prandial insulin. Three patients discontinued prandial insulin due to dissatisfaction with treatment outcome (n = 1), accidental injury (n = 1), or personal reasons (n = 1). After 24 weeks of basal-plus treatment, mean HbA1c significantly decreased (8.06% to 7.17%; p < 0.001), 65.1% of subjects achieved HbA1c ≤7%, there was no change in FBG (6.23-6.20 mmol/L; p = 0.118), and mean post-prandial blood glucose decreased (13.17-10.14 mmol/L; p < 0.001). During basal-plus treatment, three individuals experienced hypoglycemia, and no significant change in the mean subject weight was observed (73.2 vs. 73.3 kg; p = 0.379). CONCLUSIONS: In people with T2DM who are achieving suboptimal glycemic control with basal insulin plus OADs, basal insulin dose optimization followed by the addition of prandial insulin improves glycemic control, is well tolerated, and is associated with a low incidence of hypoglycemia.