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. Issue 10 (1st July 2015)

• Record Type: Journal Article
• Authors: Gough, S. C. L.; Bode, B. W.; Woo, V. C.; Rodbard, H. W.; Linjawi, S.; Zacho, M.; Reiter, P. D.; Buse, J. B.
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 10(2015:Oct.)
• Page Start: 965
• Page End: 973
• Publication Date: 2015-07-01
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12498
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12498-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12498-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12498-para-0001">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.</p> </sec> <sec id="dom12498-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12498-para-0002">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.</p> </sec> <sec id="dom12498-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12498-para-0003">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.</p> </sec> <sec id="dom12498-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="dom12498-para-0004">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.</p> </sec> </abstract>