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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
Author(s) -
Gough S. C. L.,
Bode B. W.,
Woo V. C.,
Rodbard H. W.,
Linjawi S.,
Zacho M.,
Reiter P. D.,
Buse J. B.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12498
Subject(s) - insulin degludec , liraglutide , medicine , type 2 diabetes , insulin , metformin , pioglitazone , diabetes mellitus , urology , endocrinology , gastroenterology , insulin glargine
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.