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Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes
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OBJECTIVE: The efficacy and safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated with oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS: In this 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial, 1,091 subjects were randomly assigned (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneously), to placebo, or to glimepiride (4 mg once daily). All treatments were in combination therapy with metformin (1g twice daily). Enrolled subjects (aged 25-79 years) had type 2 diabetes, A1C of 7-11% (previous OAD monotherapy for > or =3 months) or 7-10% (previous OAD combination therapy for > or =3 months), and BMI < or =40 kg/m(2). RESULTS: A1C values were significantly reduced in all liraglutide groups versus the placebo group (P < 0.0001) with mean decreases of 1.0% for 1.8 mg liraglutide, 1.2 mg liraglutide, and glimepiride and 0.7% for 0.6 mg liraglutide and an increase of 0.1% for placebo. Body weight decreased in all liraglutide groups (1.8-2.8 kg) compared with an increase in the glimepiride group (1.0 kg; P < 0.0001). The incidence of minor hypoglycemia with liraglutide ( approximately 3%) was comparable to that with placebo but less than that with glimepiride (17%; P < 0.001). Nausea was reported by 11-19% of the liraglutide-treated subjects versus 3-4% in the placebo and glimepiride groups. The incidence of nausea declined over time. CONCLUSIONS: In subjects with type 2 diabetes, once-daily liraglutide induced similar glycemic control, reduced body weight, and lowered the occurrence of hypoglycemia compared with glimepiride, when both had background therapy of metformin.
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“In these studies, mean weight change ranged from −1.0 kg to −3.78 kg over 6–12 months.”
From Real-world weight change, adherence, and discontinuation among patients with type 2 diabetes initiating glucagon-like peptide-1 receptor agonists in the UK (2022) · cites this paper as [16]
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Self-citation
Metadata
- Authors
- Nauck, 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
- Affiliations
- Diabeteszentrum Bad Lauterberg (DE)
- Öresund Diabetes Team AB, Lund, Sweden
- Aarhus University Hospital (DK)
- King Edward Memorial Hospital and Seth G.S. Medical College (IN)
- Clinic of Diabetology, Sophia, Bulgaria
- Benmed Hospital, Benoni, Republic of South Africa
- Novo Nordisk (Denmark) (DK)
- Novo Nordisk, Bagsvaerd, Denmark
- Oxford Centre for Diabetes, Endocrinology and Metabolism (GB)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2009-01-01
- Volume
- 32
- Issue
- 1
- Pages
- 84-90
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC2606836
- OpenAlex
- W2071835038
- Cited by
- 1,129
- References
- 26
- Citations by year
- 2026: 22 · 2025: 43 · 2024: 26 · 2023: 33 · 2022: 17 · 2021: 28 · 2020: 30 · 2019: 35 · 2018: 38 · 2017: 58 · 2016: 85 · 2015: 84 · 2014: 95 · 2013: 81 · 2012: 113
- FWCI
- 82.01
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Diabetes Care (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0508-10272)
- 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
- liraglutide, glimepiride, metformin, type 2 diabetes, GLP-1 receptor agonists, combination therapy, glycemic control, HbA1c, weight loss, hypoglycemia, nausea, oral antidiabetic drugs, drug safety, obesity, dose comparison
- MeSH terms
- Liraglutide, Adult, Aged, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Obesity, Placebos, Safety, Sulfonylurea Compounds, Glucagon-Like Peptide 1
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