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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
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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“This is in keeping with studies of other drug classes and different GLP1-RAs, which have shown cardiovascular outcome benefit in association with little or no weight loss.24”
From Semaglutide and cardiovascular outcomes by baseline and changes in adiposity measurements: a prespecified analysis of the SELECT trial (2025) · cites this paper as [24]
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Self-citationDrucker, D. J., & Nauck, M. A. (2006) · The Lancet · doi:10.1016/s0140-6736(06)69705-5 · Cited by 3,896
Self-citationBuse, J. B., Rosenstock, J., Sesti, G., Schmidt, W. E., Montanya, E., Brett, J. H., Zychma, M., & Blonde, L. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60659-0 · Cited by 1,503
Self-citationNauck, M., Frid, A., Hermansen, K., Shah, N. S., Tankova, T., Mitha, I. H., Zdravkovic, M., Düring, M., Matthews, D. R., & for the LEAD-2 Study Group (2009) · Diabetes Care · doi:10.2337/dc08-1355 · Cited by 1,129
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on behalf of the Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group, Russell-Jones, D., Vaag, A., Schmitz, O., Sethi, B. K., Lalic, N., Antic, S., Zdravkovic, M., Ravn, G. M., & Simó, R. (2009) · Diabetologia · doi:10.1007/s00125-009-1472-y · Cited by 835
Marre, M., Shaw, J. E., Brändle, M., Bebakar, W. M. W., Kamaruddin, N. A., Strand, J., Zdravkovic, M. D., Thi, T. D. L., Colagiuri, S., & on behalf of the LEAD‐1 SU study group (2009) · Diabetic Medicine · doi:10.1111/j.1464-5491.2009.02666.x · Cited by 821
Buse, J. B., Nauck, M., Forst, T., Sheu, W. H.-H., Shenouda, S. K., Heilmann, C. R., Hoogwerf, B. J., Gao, A., Boardman, M. K., Fineman, M., et al. (2013) · The Lancet · doi:10.1016/s0140-6736(12)61267-7 · Cited by 565
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Research works printed but not linked: 1
- Rosenstock, 2010, Albiglutide, Drugs Fut, 35, 701, 10.1358/dof.2010.35.9.1516042 · DOI
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GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art
Nauck, M. A., Quast, D. R., Wefers, J., & Meier, J. J. (2021) · Molecular Metabolism · doi:10.1016/j.molmet.2020.101102 · Cited by 1,647
“Remarkably, the reduction in MACE events with albiglutide is very much comparable if not more pronounced than with other effective GLP-1 RAs (Figure 7A) despite its reduced ability to lower HbA1c, fasting plasma glucose, and body weight in clinical trials (Figure 4) [40].”
BackgroundSelf-citationDiscovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide
Lau, J., Bloch, P., Schäffer, L., Pettersson, I., Spetzler, J., Kofoed, J., Madsen, K., Knudsen, L. B., McGuire, J., Steensgaard, D. B., et al. (2015) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.5b00726 · Cited by 1,105
Glucagon-like peptide-1 receptor: mechanisms and advances in therapy
Zheng, Z., Zong, Y., Ma, Y., Tian, Y., Pang, Y., Zhang, C., & Gao, J. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-01931-z · Cited by 1,036
“107 Further, serious risks associated with Tanzeum use include pancreatitis, acute kidney injury, renal impairment, and pneumonia, further limiting its use in speci fi c conditions or susceptible patients.”
BackgroundThe Discovery and Development of Liraglutide and Semaglutide
Knudsen, L. B., & Lau, J. (2019) · Frontiers in Endocrinology · doi:10.3389/fendo.2019.00155 · Cited by 970
Strategic Approaches to Optimizing Peptide ADME Properties
Di, L. (2015) · The AAPS Journal · doi:10.1208/s12248-014-9687-3 · Cited by 669
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)
- 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
- 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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