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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

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·2014·The Lancet Diabetes & Endocrinology
DOI 10.1016/s2213-8587(13)70214-6
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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.

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  1. Rosenstock, 2010, Albiglutide, Drugs Fut, 35, 701, 10.1358/dof.2010.35.9.1516042 · DOI

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Metadata

Authors
Pratley, R. E., Nauck, M. A., Barnett, A. H., Feinglos, M. N., Ovalle, F., Harman-Boehm, I., Ye, J., Scott, R., Johnson, S., Stewart, M., & Rosenstock, J.
Affiliations
  • Sanford Burnham Prebys Medical Discovery Institute (US)
  • Diabeteszentrum Bad Lauterberg (DE)
  • Heartlands Hospital (GB)
  • Duke University (US)
  • University of Alabama at Birmingham (US)
  • GlaxoSmithKline (United Kingdom) (GB)
  • GlaxoSmithKline (United States) (US)
Corresponding author
Pratley, Richard E
ORCID
Venue
The Lancet Diabetes & Endocrinology
Publisher
Elsevier BV
Published
2014-04
Volume
2
Issue
4
Pages
289-297
ISSN
2213-8587 (ISSN-L)
DOI
10.1016/s2213-8587(13)70214-6
OpenAlex
W2128825255
Cited by
326
References
24
Citations by year
2026: 8 · 2025: 22 · 2024: 18 · 2023: 6 · 2022: 8 · 2021: 19 · 2020: 14 · 2019: 22 · 2018: 30 · 2017: 46 · 2016: 51 · 2015: 47 · 2014: 34
FWCI
48.02
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Diabetes & Endocrinology (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • ANU Open Research (Australian National University) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
Funders
GlaxoSmithKline
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
Keywords
type 2 diabetes, albiglutide, liraglutide, GLP-1 receptor agonists, HbA1c, inadequate glycemic control, oral antidiabetic drugs, non-inferiority, dose titration, head-to-head comparison, personalized treatment, body mass index, adverse events
MeSH terms
Liraglutide, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Treatment Outcome, Glucagon-Like Peptide 1

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