Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study Article

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cited authors

  • Pratley, Richard E., Nauck, Michael A., Barnett, Anthony H., Feinglos, Mark N., Ovalle, Fernando, Harman-Boehm, Illana, Ye, June, Scott, Rhona, Johnson, Susan, Stewart, Murray, Rosenstock, Julio, HARMONY 7 Study Grp

funding text

  • GlaxoSmithKline provided funding for this study. Some data from this study were presented at the annual meetings of the American Diabetes Association in 2012 (poster 945-P) and 2013 (poster 1010-P). We thank the following employees of GlaxoSmithKline for their specific contributions: Caroline Perry for study management support, Alan Martin for management and oversight of the treatment satisfaction component within this study, and Sergio Forero-Schwanhaeuser and Douglas L Wicks for management of manuscript development. Editorial support also was provided by Beth Burke (assistance with the production of draft outline, production of the first draft, assembly of tables and figures, and collation of author comments), Joelle Suchy (assistance with the production of draft outline, production of the first draft, assembly of tables and figures, collation of author comments, fact checking, and referencing), and Tammie Anderson (MediTech Media, Hamilton, NJ, USA) for editorial project management, which was funded by GlaxoSmithKline.

abstract

  • Background As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. Methods We undertook this 32-week, open-label, phase 3 non-inferiority study at 162 sites in eight countries: USA (121 sites), Australia (9 sites), Peru (7 sites), Philippines (7 sites), South Korea (5 sites), UK (5 sites), Israel (4 sites), and Spain (4 sites). 841 adult participants (aged >= 18 years) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m(2) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6, or liraglutide 0.6 mg once daily titrated to 1.2 mg at week 1 and 1.8 mg at week 2. The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16. Participants and investigators were unmasked to treatment. The primary endpoint was change from baseline in HbA(1c) for albiglutide versus liraglutide, with a 95% CI non-inferiority upper margin of 0.3%. The primary analysis was by modified intention to treat. The study is registered with ClinicalTrials.gov, number NCT01128894. Findings 422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs. The primary endpoint analysis was done on the modified intention-to-treat population, which included 402 participants in the albiglutide group and 403 in the liraglutide group. Model-adjusted change in HbA(1c) from baseline to week 32 was -0.78% (95% CI -0.87 to -0.69) in the albigludite group and -0.99% (-1.08 to -0.90) in the liraglutide group; treatment difference was 0.21% (0.08-0.34; non-inferiority p value = 0.0846). Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide (12.9% vs 5.4%; treatment difference 7.5%[95% CI 3.6-11.4]; p = 0.0002), whereas the opposite was the case for gastrointestinal events, which occurred in 49.0% of patients in the liraglutide group versus 35.9% in the albiglutide group (treatment difference -13.1%[95% CI -19.9 to -6.4]; p = 0.00013). Interpretation Patients who received once-daily liraglutide had greater reductions in HbA(1c) than did those who received once-weekly albiglutide. Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group.

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Publication Date

  • April 1, 2014

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start page

  • 289

end page

  • 297

volume

  • 2

issue

  • 4

WoS Citations

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WoS References

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