DUAL II China: superior HbA1c reductions and weight loss with insulin degludec/liraglutide (IDegLira) versus insulin degludec in a randomized trial of Chinese people with type 2 diabetes inadequately controlled on basal insulin.

Abstract

AIMS\nIn DUAL II China, the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (degludec) were assessed in Chinese people with type 2 diabetes (T2D) treated with basal insulin.\n\n\nMATERIALS AND METHODS\nIn a randomized, double-blinded, multicentre, treat-to-target trial, Chinese adults with T2D and glycated haemoglobin (HbA1c ) ≥7.5% on basal insulin and metformin, with or without other oral-antidiabetic drugs (OADs), were randomized 2:1 to 26\u2009weeks treatment with either IDegLira (max. Dose 50\u2009U degludec/1.8\u2009mg liraglutide) or degludec (max. 50\u2009U/day), respectively, combined with metformin. At 26\u2009weeks, superiority of IDegLira over degludec was assessed for change in HbA1c (primary endpoint) and body weight and number of severe or blood glucose (BG)-confirmed hypoglycaemic episodes (confirmatory secondary endpoints).\n\n\nRESULTS\nOverall, 453 participants were randomized to IDegLira (n\xa0=\xa0302) or degludec (n\xa0=\xa0151). Superiority was confirmed for IDegLira over degludec in HbA1c change (-1.9% versus -1.0%, respectively, estimated treatment difference (ETD) [95% confidence interval]: -0.92% [-1.09;-0.75], p\u2009<\u20090.0001), body weight change (-0.7\u2009kg versus +0.4\u2009kg, respectively, ETD [95% CI]: -1.08\u2009kg [-1.63;-0.52], p\xa0=\xa00.0002) and severe or BG-confirmed hypoglycaemia (estimated rate ratio [95% CI]: 0.53 [0.30;0.94], p\xa0=\xa00.0297). The odds of achieving HbA1c \xa0<\u20097.0% without hypoglycaemia and/or weight gain were greater with IDegLira than degludec (p\u2009<\u20090.0001 for all). Daily insulin dose at 26\u2009weeks was lower for IDegLira (34.3\u2009U) than degludec (37.4\u2009U), p\xa0=\xa00.0014. No unexpected safety signals were observed.\n\n\nCONCLUSIONS\nIDegLira may be an efficacious and well-tolerated treatment intensification option for Chinese people with T2D uncontrolled on basal insulin and OADs. DUAL™ II China; ClinicalTrials.gov Identifier: NCT03175120. This article is protected by copyright. All rights reserved.