Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial
Autor: | Alan, Garber, Robert, Henry, Robert, Ratner, Pedro A, Garcia-Hernandez, Hiromi, Rodriguez-Pattzi, Israel, Olvera-Alvarez, Paula M, Hale, Milan, Zdravkovic, Bruce, Bode, G, Umpierrez |
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Rok vydání: | 2008 |
Předmět: |
Blood Glucose
Male medicine.medical_specialty Taspoglutide Blood Pressure Type 2 diabetes Gastroenterology Double-Blind Method Glucagon-Like Peptide 1 Internal medicine Diabetes mellitus medicine Humans Hypoglycemic Agents Glycated Hemoglobin business.industry Liraglutide Type 2 Diabetes Mellitus General Medicine Middle Aged medicine.disease Albiglutide Glimepiride Endocrinology Sulfonylurea Compounds Diabetes Mellitus Type 2 Female medicine.symptom business Weight gain medicine.drug |
Zdroj: | Lancet (London, England). 373(9662) |
ISSN: | 1474-547X |
Popis: | New treatments for type 2 diabetes mellitus are needed to retain insulin-glucose coupling and lower the risk of weight gain and hypoglycaemia. We aimed to investigate the safety and efficacy of liraglutide as monotherapy for this disorder.In a double-blind, double-dummy, active-control, parallel-group study, 746 patients with early type 2 diabetes were randomly assigned to once daily liraglutide (1.2 mg [n=251] or 1.8 mg [n=247]) or glimepiride 8 mg (n=248) for 52 weeks. The primary outcome was change in proportion of glycosylated haemoglobin (HbA(1c)). Analysis was done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NTC00294723.At 52 weeks, HbA(1c) decreased by 0.51% (SD 1.20%) with glimepiride, compared with 0.84% (1.23%) with liraglutide 1.2 mg (difference -0.33%; 95% CI -0.53 to -0.13, p=0.0014) and 1.14% (1.24%) with liraglutide 1.8 mg (-0.62; -0.83 to -0.42, p0.0001). Five patients in the liraglutide 1.2 mg, and one in 1.8 mg groups discontinued treatment because of vomiting, whereas none in the glimepiride group did so.Liraglutide is safe and effective as initial pharmacological therapy for type 2 diabetes mellitus and leads to greater reductions in HbA(1c), weight, hypoglycaemia, and blood pressure than does glimepiride. |
Databáze: | OpenAIRE |
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