| Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. | |
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MedLine Citation:
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PMID: 20824678 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Dipeptidyl peptidase-4 inhibitors improve glycaemic control in patients with type 2 diabetes mellitus when used as monotherapy or in combination with other anti-diabetic drugs (metformin, sulphonylurea, or thiazolidinedione). This 18-week, phase 3b, multicentre, double-blind, noninferiority trial compared the efficacy and safety of two dipeptidyl peptidase-4 inhibitors, saxagliptin and sitagliptin, in patients whose glycaemia was inadequately controlled with metformin. METHODS: Adult type 2 diabetes mellitus patients (N = 801) with glycated haemoglobin (HbA(1c)) 6.5-10% on stable metformin doses (1500-3000 mg/day) were randomized 1 : 1 to add-on 5 mg saxagliptin or 100 mg sitagliptin once daily for 18 weeks. The primary efficacy analysis was a comparison of the change from baseline HbA(1c) at week 18 in per-protocol patients. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the HbA(1c) difference between treatments was < 0.3%. RESULTS: The adjusted mean changes in HbA(1c) following the addition of saxagliptin or sitagliptin to stable metformin therapy were - 0.52 and - 0.62%, respectively. The between-group difference was 0.09% (95% confidence interval, - 0.01 to 0.20%), demonstrating noninferiority. Both treatments were generally well tolerated; incidence and types of adverse events were comparable between groups. Hypoglycaemic events, mostly mild, were reported in approximately 3% of patients in each treatment group. Body weight declined by a mean of 0.4 kg in both groups. CONCLUSIONS: Saxagliptin added to metformin therapy was effective in improving glycaemic control in patients with type 2 diabetes mellitus inadequately controlled by metformin alone; saxagliptin plus metformin was noninferior to sitagliptin plus metformin, and was generally well tolerated. |
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Authors:
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André J Scheen; Guillaume Charpentier; Carl Johan Ostgren; Asa Hellqvist; Ingrid Gause-Nilsson |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Diabetes/metabolism research and reviews Volume: 26 ISSN: 1520-7560 ISO Abbreviation: Diabetes Metab. Res. Rev. Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-09-30 Completed Date: 2011-01-27 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883450 Medline TA: Diabetes Metab Res Rev Country: England |
Other Details:
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Languages: eng Pagination: 540-9 Citation Subset: IM |
Affiliation:
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University of Liège, Division of Diabetes, Nutrition and Metabolic Disorders and Clinical Pharmacology Unit, CHU Liège, Liège, Belgium. Andre.Scheen@chu.ulg.ac.be |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adamantane
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adverse effects,
analogs & derivatives*,
therapeutic use Aged Blood Glucose / drug effects Diabetes Mellitus, Type 2 / drug therapy* Dipeptides / adverse effects, therapeutic use* Dipeptidyl-Peptidase IV Inhibitors / adverse effects, therapeutic use* Drug Therapy, Combination Female Hemoglobin A, Glycosylated / analysis Humans Hypoglycemic Agents / adverse effects, therapeutic use* Male Metformin / adverse effects, therapeutic use* Middle Aged Pyrazines / adverse effects, therapeutic use* Treatment Outcome Triazoles / adverse effects, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose; 0/Dipeptides; 0/Dipeptidyl-Peptidase IV Inhibitors; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Pyrazines; 0/Triazoles; 0/hemoglobin A1c protein, human; 0/saxagliptin; 0/sitagliptin; 281-23-2/Adamantane; 657-24-9/Metformin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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