Cited by 1,129Diabetes Treatment and ManagementDiabetes Management and ResearchPharmacology and Obesity Treatment

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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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Nauck, Michael, Frid, Anders, Hermansen, Kjeld, Shah, Nalini S., Tankova, Tsvetalina, Mitha, Ismail H., Zdravkovic, Milan, Düring, Maria, Matthews, David R., for the LEAD-2 Study Group·2009·Diabetes Care

DOI 10.2337/dc08-1355PMC PMC2606836

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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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Figure 1 A1C profiles for the overall study population (A), for subjects with prestudy oral monotherapy (B), and for subjects with prestudy oral combination therapy (C). D: Change in A1C for the overall study population and for subjects treated by prestudy monotherapy or combination therapy. Error bars in A, B, C, and D represent 2 × SEM. Percentages of subjects achieving ADA (E) and AACE (F) A1C goals at the end of the study were determined using a logistic regression analysis. Symbols for A–C: pink boxes, 0.6 mg/day liraglutide; circles, 1.2 mg/day liraglutide; diamonds, 1.8 mg/day liraglutide; triangles, 4 mg/day glimepiride; gray boxes, placebo. QD, every day.CC BY-NC-ND · PubMed Central

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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)
ORCID: Nauck, Michael
Hermansen, Kjeld
Shah, Nalini S.
Tankova, Tsvetalina
Matthews, David R.
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
DOI: 10.2337/dc08-1355
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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Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes

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