In:
Diabetes, Obesity and Metabolism, Wiley, Vol. 17, No. 2 ( 2015-02), p. 179-187
Kurzfassung:
To investigate the efficacy and tolerability of albiglutide, a weekly glucagon‐like peptide‐1 receptor agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus. Methods This was a 156‐week, randomized, double‐blind, parallel‐group, multicentre study. In the present paper we describe the primary results, namely those at 52 weeks. Adult participants (n = 685) were randomly assigned to albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant's current dose of metformin ( 〉 1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycaemia occurred. Results The week 52 model‐adjusted difference in change of glycated haemoglobin (primary endpoint) for albiglutide versus placebo was ‐0.87 [95% confidence interval ( CI ) –1.07, –0.68]%‐units (p 〈 0.001), and for albiglutide versus pioglitazone it was 0.25 (95% CI 0.10, 0.40)%‐units; therefore, not non‐inferior. In the albiglutide group only, fasting plasma glucose reduced rapidly in the first 2 weeks. Confirmed hypoglycaemia occurred in 14% of participants on albiglutide, 25% on pioglitazone and 14% on placebo. The mean (± standard error) weight change was −0.42 (±0.2) kg with albiglutide, +4.4 (±0.2) kg (p 〈 0.001) with pioglitazone, and −0.40 (±0.4) kg with placebo and serious adverse events occurred in 6.3, 9.0 and 6.1% of participants in the respective groups. Injection site reactions occurred in 13% of participants on albiglutide and resulted in treatment discontinuation for four participants (1.4%). Conclusions Albiglutide, as part of triple therapy, provided effective glucose‐lowering and was generally well tolerated.
Materialart:
Online-Ressource
ISSN:
1462-8902
,
1463-1326
DOI:
10.1111/dom.2015.17.issue-2
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2015
ZDB Id:
2004918-3
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