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Aims  To confirm, in a 26‐week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide ( IDegLira ) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes.    Methods  Insulin‐naïve adults with type 2 diabetes randomized to once‐daily  IDegLira , insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26‐week extension of the  DUAL I  trial.    Results  A total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin ( HbA1c ) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the  IDegLira  group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on  IDegLira , 78% achieved an  HbA1c  of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for  IDegLira  (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with  IDegLira  (39 units) than with insulin degludec (62 units).  IDegLira  was associated with a significantly greater decrease in body weight (estimated treatment difference, −2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for  IDegLira .    Conclusions  These 12‐month data, derived from a 26‐week extension of the  DUAL I  trial, confirm the initial 26‐week main phase results and the sustainability of the benefits of  IDegLira  compared with its components in glycaemic efficacy, safety and tolerability.

diabetes, obesity and metabolism

One‐year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26‐week extension to a 26‐week main trial