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Aim  To investigate the safety and efficacy of insulin degludec/liraglutide ( ID egLira), a novel combination product, as add‐on therapy for people with Type 2 diabetes uncontrolled on sulphonylurea therapy.    Methods  In this 26‐week, double‐blind trial, adults with Type 2 diabetes [HbA 1c  53–75 mmol/mol (7.0–9.0%)] were randomized to  ID egLira ( n  = 289) or placebo ( n  = 146) as add‐on to pre‐trial sulphonylurea ± metformin, titrating to a fasting glycaemic target of 4.0–6.0 mmol/l. Treatment initiation was at 10 dose steps, and maximum dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide).    Results  The mean HbA 1c  decreased from 63 mmol/mol (7.9%) to 46 mmol/mol (6.4%) with  ID egLira and to 57 mmol/mol (7.4%) with placebo [estimated treatment difference –11 mmol/mol (95%  CI  –13; –10) or –1.02% (95%  CI  –1.18; –0.87);  P  < 0.001]. The HbA 1c  target of 53 mmol/mol (<7%) was achieved by 79.2% of participants in the  ID egLira group vs 28.8% in the placebo group [estimated odds ratio 11.95 (95%  CI  7.22; 19.77);  P  < 0.001]. Mean weight change was +0.5 kg with  ID egLira vs –1.0 kg with placebo [estimated treatment difference 1.48 kg (95%  CI  0.90; 2.06);  P  < 0.001]. Confirmed hypoglycaemia occurred in 41.7 and 17.1% of  ID egLira‐ and placebo‐treated participants, respectively, with rates of 3.5 vs 1.4 events/patient‐years of exposure [estimated rate ratio 3.74 (95%  CI  2.28; 6.13);  P  < 0.001].  ID egLira was generally well tolerated. The rates of serious adverse events were 20.3 and 8.0 per 100 patient‐years of exposure with  ID egLira and placebo, respectively, without obvious patterns in the type of events.    Conclusions   ID egLira can be used in people uncontrolled with sulphonylurea ± metformin to improve efficacy with a safety profile in line with previous  DUAL  trials.

diabetic medicine

Safety and efficacy of insulin degludec/liraglutide ( ID egLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin‐naïve people with Type 2 diabetes: the  DUAL IV  trial