| The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. | |
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MedLine Citation:
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PMID: 21410627 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background: Initial combination therapy with the fixed-dose combination (FDC) of sitagliptin and metformin is a potential approach to achieve more effective glycemic control vs. metformin monotherapy. Methods: This double-blind study (18-week Phase A and 26-week Phase B) randomized 1250 drug-naïve patients with type 2 diabetes (mean baseline HbA(1c) 9.9%) to sitagliptin/metformin 50/500 mg b.i.d. or metformin 500 mg b.i.d. (up-titrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg b.i.d. or metformin 1000 b.i.d.). Results of the primary efficacy endpoint (mean HbA(1c) reductions from baseline at the end of Phase A) are reported herein. Results: At Week 18, mean change from baseline HbA(1c) was -2.4% for sitagliptin/metformin FDC and -1.8% for metformin monotherapy (p < 0.001); more patients treated with sitagliptin/metformin FDC had an HbA(1c) value <7% (p < 0.001) vs. metformin monotherapy. Changes in fasting plasma glucose were significantly greater with sitagliptin/metformin FDC (-3.8 mmol/L) vs. metformin monotherapy (-3.0 mmol/L; p < 0.001). HOMA-β and fasting proinsulin/insulin ratio were significantly improved with sitagliptin/metformin FDC vs. metformin monotherapy. Baseline body weight was reduced by 1.6 kg in each group. Both treatments were generally well tolerated with a low and similar incidence of hypoglycemia. Abdominal pain (1.1% and 3.9%; p=0.002) and diarrhea (12.0% and 16.6%; p=0.021) occurred significantly less with sitagliptin/metformin FDC vs. metformin monotherapy; the incidence of nausea and vomiting was similar in both groups. Conclusion: Compared with metformin monotherapy, initial treatment with sitagliptin/metformin FDC provided superior glycemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhea. |
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Authors:
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C Reasner; L Olansky; T L Seck; D E Williams-Herman; M Chen; L Terranella; A O Johnson-Levonas; K D Kaufman; B J Goldstein |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-3-15 |
Journal Detail:
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Title: Diabetes, obesity & metabolism Volume: - ISSN: 1463-1326 ISO Abbreviation: - Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-3-17 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883645 Medline TA: Diabetes Obes Metab Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2011 Blackwell Publishing Ltd. |
Affiliation:
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University of Texas, San Antonio, TX, USA Cleveland Clinic Foundation, Cleveland, OH, USA Merck Research Laboratories, Rahway, NJ, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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