Exenatide once weekly versus liraglutide once daily in patients with type 2
diabetes (DURATION-6): a randomised, open-label study.
Author(s): Buse JB(1), Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao
A, Boardman MK, Fineman M, Porter L, Schernthaner G.
Affiliation(s): Author information:
(1)University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Publication date & source: 2013, Lancet. , 381(9861):117-24
BACKGROUND: Glucagon-like peptide-1 receptor agonists exenatide and liraglutide
have been shown to improve glycaemic control and reduce bodyweight in patients
with type 2 diabetes. We compared the efficacy and safety of exenatide once
weekly with liraglutide once daily in patients with type 2 diabetes.
METHODS: We did a 26 week, open-label, randomised, parallel-group study at 105
sites in 19 countries between Jan 11, 2010, and Jan 17, 2011. Patients aged 18
years or older with type 2 diabetes treated with lifestyle modification and oral
antihyperglycaemic drugs were randomly assigned (1:1), via a computer-generated
randomisation sequence with a voice response system, to receive injections of
once-daily liraglutide (1·8 mg) or once-weekly exenatide (2 mg). Participants and
investigators were not masked to treatment assignment. The primary endpoint was
change in glycated haemoglobin (HbA(1c)) from baseline to week 26. Analysis was
by intention to treat. This trial is registered with ClinicalTrials.gov, number
NCT01029886.
FINDINGS: Of 912 randomised patients, 911 were included in the intention-to-treat
analysis (450 liraglutide, 461 exenatide). The least-squares mean change in
HbA(1c) was greater in patients in the liraglutide group (-1·48%, SE 0·05; n=386)
than in those in the exenatide group (-1·28%, 0·05; 390) with the treatment
difference (0·21%, 95% CI 0·08-0·33) not meeting predefined non-inferiority
criteria (upper limit of CI <0·25%). The most common adverse events were nausea
(93 [21%] in the liraglutide group vs 43 [9%] in the exenatide group), diarrhoea
(59 [13%] vs 28 [6%]), and vomiting 48 [11%] vs 17 [4%]), which occurred less
frequently in the exenatide group and with decreasing incidence over time in both
groups. 24 (5%) patients allocated to liraglutide and 12 (3%) allocated to
exenatide discontinued participation because of adverse events.
INTERPRETATION: Both once daily liraglutide and once weekly exenatide led to
improvements in glycaemic control, with greater reductions noted with
liraglutide. These findings, plus differences in injection frequency and
tolerability, could inform therapeutic decisions for treatment of patients with
type 2 diabetes.
FUNDING: Eli Lilly and Company and Amylin Pharmaceuticals LLC.
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