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A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes
Open accessAbstract
OBJECTIVE: To investigate the dose-response relationship of semaglutide versus placebo and open-label liraglutide in terms of glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This was a 12-week, randomized, double-blind phase 2 trial. Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1–0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1–2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo. The primary end point was change in HbA1c level from baseline. Secondary end points included change in body weight, safety, and tolerability. RESULTS: Semaglutide dose-dependently reduced the level of HbA1c from baseline (8.1 ± 0.8%) to week 12 by up to −1.7%, and body weight by up to −4.8 kg (1.6 mg E, P < 0.001 vs. placebo). Up to 81% of patients achieved an HbA1c level of <7%. HbA1c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs), but adverse events (AEs) and withdrawals occurred more frequently. The incidence of nausea, vomiting, and withdrawal due to gastrointestinal AEs increased with the semaglutide dose; most events were mild to moderate, transient, and ameliorated by dose escalation. There were no major episodes of hypoglycemia and few cases of injection site reactions. CONCLUSIONS: After 12 weeks, semaglutide dose-dependently reduced HbA1c level and weight in patients with type 2 diabetes. No unexpected safety or tolerability concerns were identified; gastrointestinal AEs typical of glucagon-like peptide 1 receptor agonists were mitigated by dose escalation. On this basis, weekly semaglutide doses of 0.5 and 1.0 mg with a 4-week dose escalation were selected for phase 3.
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“The longer half-life of AMG 133 (mean t1/2 ~ 21 d) along with the duration of weight loss seen after a single dose as well as repeat dosing of AMG 133 enabled less-frequent dosing at every 4 weeks in the MAD study compared to other GLP-1 agonists and dual GIPR/GLP-1 agonists, which require either daily or weekly dosing based on the shorter half-lives of these agents20,42,43.”
From A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings (2024) · cites this paper as [43]
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Metadata
- Authors
- Nauck, M. A., Petrie, J. R., Sesti, G., Mannucci, E., Courrèges, J.-P., Lindegaard, M. L., Jensen, C. B., & Atkin, S. L.
- Affiliations
- Diabeteszentrum Bad Lauterberg (DE)
- University of Glasgow (GB)
- Magna Graecia University (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- General Hospital, Narbonne, France
- Novo Nordisk (Denmark) (DK)
- Weill Cornell Medical College in Qatar (QA)
- Corresponding author
- Nauck, Michael A.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2015-09-10
- Volume
- 39
- Issue
- 2
- Pages
- 231-241
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2117764934
- Cited by
- 233
- References
- 14
- Citations by year
- 2026: 17 · 2025: 26 · 2024: 25 · 2023: 22 · 2022: 20 · 2021: 15 · 2020: 10 · 2019: 21 · 2018: 28 · 2017: 32 · 2016: 14 · 2015: 2
- FWCI
- 21.97
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Funders
- Science and Engineering Research Board
- 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
- semaglutide, liraglutide, type 2 diabetes, GLP-1 receptor agonists, glycemic control, HbA1c, weight loss, dose escalation, nausea and vomiting, gastrointestinal adverse effects, hypoglycemia, injection site reactions, drug safety and tolerability, dose-response relationship, open-label extension
- MeSH terms
- Liraglutide, Semaglutide, Adult, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Glucagon-Like Peptides, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Injections, Subcutaneous, Male, Middle Aged, Nausea, Vomiting, Treatment Outcome
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