DUAL I China:在一项对未服用口服降糖药物的中国2型糖尿病患者进行的随机试验中, IDegLira与其单独成分相比改善了血糖控制

Abstract

Abstract Background DUAL I China, one of the DUAL trials, assessed efficacy/safety of insulin degludec/liraglutide (IDegLira) in Chinese adults with type 2 diabetes (T2D) not controlled by oral antidiabetic drugs (OADs). Methods This phase 3a, treat‐to‐target multicenter trial randomized participants (glycated hemoglobin [HbA1c] 53.0‐85.8 mmol/mol; previous metformin ± another OAD) 2:1:1 to IDegLira (n = 361), degludec (n = 179), or liraglutide (n = 180). Primary endpoint was change in HbA1c after 26 weeks. Secondary endpoints included: HbA1c < 53.0 mmol/mol attainment, weight change, treatment‐emergent hypoglycemia, end‐of‐treatment insulin dose, and safety. Results At 26 weeks, HbA1c had decreased by a mean 18.12 mmoL/moL (IDegLira), 12.37 mmoL/moL (degludec) (estimated treatment difference [ETD] −6.50 mmoL/moL; 95% confidence interval [CI] −7.96, −5.04; P < .0001), and 11.33 mmoL/moL (liraglutide) (ETD −6.87 mmoL/moL; 95% CI −8.33, −5.41; P < 0.0001), indicating noninferiority for IDegLira vs degludec and superiority vs liraglutide. HbA1c < 53.0 mmoL/moL attainment was 77.0% (IDegLira), 46.4% (degludec), and 48.3% (liraglutide). Mean weight change with IDegLira (0.1 kg) was superior to degludec (1.2 kg) (ETD −1.08 kg; 96% CI −1.55, −0.62; P < 0.0001). Severe or confirmed hypoglycemic event rates were 0.24 (IDegLira) and 0.17 (degludec) episodes/participant‐year (estimated rate ratio 1.46; 95% CI 0.71, 3.02; P = .3008, not significant). At the end of treatment, the IDegLira insulin dose was lower (24.5 U/d) vs degludec (30.3 U/d) (ETD −5.49 U; 95% CI −7.77, −3.21; P < 0.0001). No unexpected safety issues occurred. Conclusions IDegLira is efficacious and well tolerated in Chinese adults with T2D not controlled by OADs.

Keywords

• 中国
• 临床试验
• 胰岛素
• 利拉鲁肽
• 2型糖尿病