Basal Insulin Regimen vs. Twice Daily Premix Insulin Regimen after Short -Term Intensive Insulin Therapy (SIT) in Patients with Type 2 Diabetes (T2D): A Multicenter, Open-Label Randomized Controlled Trial

Premixed insulin is the most commonly used insulin in China. This trial compared the efficacy and safety of once-daily insulin glargine 100 U/mL (Gla-100) + oral antihyperglycemic drugs (OADs) and twice-daily insulin aspart 70/30 (Asp 30) + OAD in T2D patients. Chinese adults with T2D receiving stable doses of metformin and 1-2 OADs with HbA1c 7.5%-11.0% were enrolled and entered a 7-10 day SIT period in which they were treated with basal-bolus to achieve a fasting blood glucose (FBG) <7 mmol/L and 2-hour postprandial glucose (2hPG) <10 mmol/L. Patients were then randomized 1:1 to receive Gla-100 + OADs (n=192) or Asp 30 + OAD (n=192) for 24 weeks. Baseline characteristics were balanced across groups. Mean (SD) age was 54.2 (8.8) years, BMI was 26.0 (3.1) kg/m2, and duration of diabetes was 6.8 (3.0) years. At week 24, the least square mean (SE) change from baseline in HbA1c was -1.72% (0.07) and -1.70% (0.07) in the Gla-100 and Asp 30 groups, respectively (Table); group difference (-0.01%; 95% CI -0.20, 0.17) met the pre-specified non-inferiority criteria (upper bound 95% CI <0.4%). All hypoglycemia events were significantly lower in the Gla-100 group.In conclusion, compared with Asp 30 + OAD, Gla-100 + OAD showed similar efficacy but lower hypoglycemia risk in Chinese T2D patients.View largeDownload slideView largeDownload slide DisclosureY. Mu: Speaker’s Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi-Aventis. J. Liu: Employee; Self; Sanofi China. X. Zhang: None. N. Cui: Employee; Self; Sanofi China. H. Yin: None. L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China. H. Wan: None. J. Wang: None. B. Xu: None. G. Wang: None. C. Jiang: None. L. Liang: None. W. Feng: Employee; Self; Sanofi China.FundingSanofi China (NCT03359837)