Journal of diabetes · 2022
DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wang Weiqing, Agner Bue F Ross, Luo Bin, Liu Lei, Liu Ming, Peng Yongde, Qu Shen, Stachlewska Karolina Amelia, Wang Guixia, Yuan Guoyue, Zhang Qiu, Ning Guang
Аннотация
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.
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.