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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
Author(s) -
Rodbard H. W.,
Bode B. W.,
Harris S. B.,
Rose L.,
Lehmann L.,
Jarlov H.,
Thurman J.
Publication year - 2017
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13256
Subject(s) - liraglutide , medicine , metformin , placebo , type 2 diabetes , diabetes mellitus , insulin , endocrinology , gastroenterology , odds ratio , alternative medicine , pathology
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.