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Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-97. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.

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.

Collaborators (154)

Adamson K, Ahmann A, Ahn CW, Ajani D, Akright L, Alwine L, Alzohaili O, Andrawis N, Arbañil Huaman H, Arora S, Bailey T, Barnett A, Baron M, Barreda Caceres L, Barrera J, Berg J, Bertenshaw R, Bode B, Bolton D, Brito M, Brock S, Brockmyre A, Broker R, Brusco O Jr, Buynak R, Canadas-Zizzias R, Canas G, Capo J, Castillo Gamarra M, Cathcart H, Catindig EA, Chilka S, Cho YW, Choi DS, Chuck L, Cooper M, Corder C, Cruz H, Darzy K, de la Rosa R, De Teresa L, DeGarmo R, D'Emden M, Denopol M, DiGiovanna M, Escalante D, Fakih F, Farris N, Feinglos M, Fillmore R, Fitz-Patrick D, Forker A, Fulcher G, Gabra N, Gabriel J, Gerstman M, Glaser L, Gnudi L, Gonzales Bravo L, Gonzalez E, Graf R, Greenwald M, Grunberger G, Harman-Boehm I, Herskovits T, Higgins A, Hoekstra J, Hollander P, Hubach E, Huff man D, Ison R, Jang HC, Jimeno C, Jones S, Karl J, Kemp S, Ketels C, Kipnes M, Knopke C, Kolettis E, Lacour A, Ledesma G, Lee D, Lefebvre G, Liljenquist D, Lipetz R, Look M, Lucas K, Luna Figueroa A, Maletz L, Marar I, Mathur R, Mayeda S, McCartney M, McGill J, Metz D, Mihalyi D, Min KW, Minuchin O, Mirasol R, Nelson D, Nolan C, Norwood P, Oberoi M, Ovalle F, Pace D, Pace M, Pappas J, Patel N, Patron A, Powell S, Pratley R, Proietto J, Rendell M, Roberts A, Rosen R, Rosenblit P, Rosenstock J, Rothman J, Ruoff G, Russell A, Samuels B, Sanderlin D, Sanders R, Schmidt J, Selam JL, Severance R, Sewell M, Shachar S, Simpson R, Smith T, Solis Villanueva J, Soto A, Sparks J, Stephens J, Stewart R, Streja D, Strzinek R, Sy RA, Teniola S, Tidman R, Toro H, Upender R, Urgeles Planella JR, Valitutto M, Vishlitzky V, Wade R, Wahle J, Weissman P, Williams D, Yao C, Ygpuara MD, Yue D, Zapata Rincón L.

Author information

1
Florida Hospital Diabetes and Translational Research Institute, Sanford-Burnham Medical Research Institute, Orlando, FL, USA. Electronic address: richard.pratley@flhosp.org.
2
Diabeteszentrum Bad Lauterberg, Harz, Germany.
3
Birmingham Heartlands Hospital, Birmingham, UK.
4
Duke University, Durham, NC, USA.
5
University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
6
Ben-Gurion University of the Negev, Beer Sheva, Israel.
7
GlaxoSmithKline, Research Triangle Park, NC, USA.
8
GlaxoSmithKline, Stevenage, Hertfordshire, UK.
9
GlaxoSmithKline, Upper Merion, PA, USA.
10
Dallas Diabetes and Endocrine Center, Dallas, TX, USA.

Erratum in

  • Lancet Diabetes Endocrinol. 2014 Mar;2(3):e5.

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 HbA1c 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 HbA1c 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 HbA1c 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.

FUNDING:

GlaxoSmithKline.

Comment in

PMID:
24703047
DOI:
10.1016/S2213-8587(13)70214-6
[Indexed for MEDLINE]

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