期刊
DIABETES OBESITY & METABOLISM
卷 18, 期 3, 页码 249-257出版社
WILEY
DOI: 10.1111/dom.12602
关键词
dulaglutide; GLP-1 receptor agonist; liraglutide; type 2 diabetes
资金
- Eli Lilly Japan K.K. (Kobe, Japan)
- Grants-in-Aid for Scientific Research [26461329] Funding Source: KAKEN
Aims: To examine the efficacy and safety of once-weekly dulaglutide 0.75mg monotherapy compared with once-daily liraglutide 0.9 mg in Japanese patients with type 2 diabetes (T2D) for 52 weeks. Methods: We conducted a phase III, randomized, 52-week (26-week primary endpoint), active-and placebo-controlled trial comparing 492 Japanese patients (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70). Participants and investigators were blinded to treatment assignment for dulaglutide and placebo but not for liraglutide (open-label comparator); after 26 weeks, patients randomized to placebo were switched to once-weekly dulaglutide 0.75mg (open-label). The present paper reports results for patients treated with dulaglutide and patients treated with liraglutide for 52 weeks. Results: At week 52, dulaglutide decreased HbA1c significantly from baseline compared with liraglutide [ least squares mean difference: -0.20; 95% confidence interval (CI) -0.39, -0.01; p = 0.04]. At week 52 (last observation carried forward), dulaglutide significantly decreased pre- and post-dinner blood glucose (BG) levels, the mean of seven-point self-monitored BG profiles, the mean of all postprandial BG levels and circadian variation compared with liraglutide. Body weight was generally stable in both groups through 52 weeks. The most frequently reported adverse events were nasopharyngitis, constipation, nausea and diarrhoea. Eight dulaglutide-treated (2.9%) and four liraglutide-treated (2.9%) patients reported hypoglycaemia, with no event being severe. Conclusions: Monotherapy with once-weekly dulaglutide 0.75mg was effective and safe in Japanese patients with T2D, with better glycaemic control compared with once-daily liraglutide 0.9 mg.
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