A 26-week randomized controlled trial of semaglutide once daily versus liraglutide and placebo in patients with type 2 diabetes suboptimally controlled on diet and exercise with or without metformin.

Lingvay, Ildiko; Desouza, Cyrus V.; Lalic, Katarina S.; Rose, Ludger; Hansen, Thomas; Zacho, Jeppe; Pieber, Thomas R.

doi:10.2337/dc17-2381

Cited by 83Diabetes Treatment and ManagementDiabetes Management and ResearchPharmacology and Obesity Treatment

A 26-week randomized controlled trial of semaglutide once daily versus liraglutide and placebo in patients with type 2 diabetes suboptimally controlled on diet and exercise with or without metformin.

Lingvay, Ildiko, Desouza, Cyrus V., Lalic, Katarina S., Rose, Ludger, Hansen, Thomas, Zacho, Jeppe, Pieber, Thomas R.·2018·Diabetes Care

DOI 10.2337/dc17-2381

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Abstract

OBJECTIVE: To investigate the efficacy and safety of once-daily semaglutide in comparison with once-daily liraglutide and placebo in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This 26-week, multicenter, double-blind trial involved patients diagnosed with type 2 diabetes with HbA1c 7.0–10.0% (53–86 mmol/mol) and treated with diet and exercise with or without metformin. Patients were randomized 2:2:1 to once-daily semaglutide, liraglutide, or placebo in one of four volume-matched doses (semaglutide 0.05, 0.1, 0.2, or 0.3 mg and liraglutide 0.3, 0.6, 1.2, or 1.8 mg, with both compared within each volume-matched dose group). Primary end point was change in HbA1c from baseline to week 26. RESULTS: In total, 705 randomized patients were exposed to trial products. At week 26, a dose-dependent change in HbA1c was observed with semaglutide from −1.1% (0.05 mg) to −1.9% (0.3 mg) and with liraglutide from −0.5% (0.3 mg) to −1.3% (1.8 mg) (all P < 0.001 in favor of volume-matched semaglutide dose). Change with pooled placebo was −0.02% (P < 0.0001 vs. semaglutide). Gastrointestinal (GI) disorders were the most common adverse events (AEs) with semaglutide and liraglutide, occurring in 32.8–54.0% and 21.9–41.5% of patients, respectively. CONCLUSIONS: Once-daily semaglutide at doses up to 0.3 mg/day resulted in greater reductions in HbA1c compared with liraglutide or placebo but with a higher frequency of GI AEs.

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Authors: Lingvay, I., Desouza, C. V., Lalic, K. S., Rose, L., Hansen, T., Zacho, J., & Pieber, T. R.
Affiliations: The University of Texas Southwestern Medical Center (US)
University of Nebraska Medical Center (US)
University of Belgrade (RS)
Institute for Diabetes Research in Münster, Münster, Germany
Novo Nordisk (Denmark) (DK)
Medical University of Graz (AT)
Corresponding author: Pieber, Thomas R.
ORCID: Lingvay, Ildiko
Desouza, Cyrus V.
Lalic, Katarina S.
Pieber, Thomas R.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2018-07-19
Volume: 41
Issue: 9
Pages: 1926-1937
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc17-2381
OpenAlex: W2884645397
Cited by: 81
References: 23
Citations by year: 2026: 8 · 2025: 13 · 2024: 9 · 2023: 10 · 2022: 12 · 2021: 9 · 2020: 6 · 2019: 10 · 2018: 3
FWCI: 5.57
Type: journal article
Language: en
Open access: closed
Licence: www.diabetesjournals.org/content/license (vor, 34 d)
Locations: Diabetes Care (publishedVersion)
PubMed (publishedVersion)
Funders: Novo Nordisk
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 › Pharmacology and Obesity Treatment
Keywords: semaglutide, liraglutide, type 2 diabetes, glycemic control, HbA1c, GLP-1 receptor agonists, metformin, diet and exercise, dose-response relationship, gastrointestinal adverse effects, placebo comparison
MeSH terms: Liraglutide, Semaglutide, Adult, Aged, Combined Modality Therapy, Diabetes Mellitus, Type 2, Diet, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Glucagon-Like Peptides, Female, Glycated Hemoglobin, Humans, Male, Metformin, Middle Aged, Placebos, Exercise, Treatment Outcome

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A 26-week randomized controlled trial of semaglutide once daily versus liraglutide and placebo in patients with type 2 diabetes suboptimally controlled on diet and exercise with or without metformin.

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