| Efficacy and safety of saxagliptin added to metformin in Asian patients with type 2 diabetes mellitus: A randomized controlled trial. | |
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MedLine Citation:
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PMID: 21871686 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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AIM: To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone. METHODS: Adults (HbA(1c) 7.0-10.0%, on stable metformin ≥1500mg/day) were randomized 1:1 to saxagliptin 5mg daily plus metformin (n=283) or placebo plus metformin (n=287). The primary end point was HbA(1c) change from baseline to Week 24. RESULTS: Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin (p≤0.0052) in HbA(1c) (-0.78% versus -0.37%), fasting plasma glucose (-1.14mmol/L versus -0.58mmol/L), and postprandial glucose area under the curve from 0 to 180min (-315mmolmin/L versus -160mmolmin/L). Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response (HbA(1c)<7.0%) (46.5% versus 30.5%; p=0.0001). The proportion of patients experiencing adverse events (excluding hypoglycemia) was similar for saxagliptin plus metformin (42.8%) versus placebo plus metformin (40.8%). Hypoglycemic events were reported in 1.4% of patients in each group. CONCLUSION: Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification. |
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Authors:
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Wenying Yang; Chang Yu Pan; Conrad Tou; June Zhao; Ingrid Gause-Nilsson |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-8-25 |
Journal Detail:
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Title: Diabetes research and clinical practice Volume: - ISSN: 1872-8227 ISO Abbreviation: - Publication Date: 2011 Aug |
Date Detail:
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Created Date: 2011-8-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8508335 Medline TA: Diabetes Res Clin Pract Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 Elsevier Ireland Ltd. All rights reserved. |
Affiliation:
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Department of Endocrinology, China-Japan Friendship Hospital, Yinhua No. 2 East Road, Hepingli, Chao Yang District, Beijing 100029, China. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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