| Effect of Saxagliptin as Add-On Therapy in Patients With Poorly Controlled Type 2 Diabetes on Insulin Alone or Insulin Combined With Metformin. | |
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MedLine Citation:
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PMID: 22313154 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Abstract Objective: To evaluate efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes (T2D) with inadequate glycaemic control on insulin alone or combined with metformin. Methods: Adults (n=455) with HbA(1c) 7.5-11% on stable insulin therapy (30-150 U/d ± metformin) for at least 8 weeks were stratified by metformin use and randomly assigned 2:1 to receive saxagliptin 5 mg or placebo once daily for 24 weeks. Patients were to maintain stable insulin doses but these could be decreased to reduce risk of hypoglycaemia. Patients with hyperglycaemia or substantially increased insulin use were rescued with a flexible insulin regimen and remained in the study. Metformin doses were kept stable. The primary efficacy endpoint was change in HbA(1c) from baseline to week 24 (or rescue). Results: Patients treated with saxagliptin versus placebo had significantly greater reductions in adjusted mean HbA(1c) (difference: -0.41%, p <0.0001), postprandial glucose (PPG) 180-minute area-under-the-curve (-3829.8 mg•min/dL, p=0.0011), and 120-minute PPG (-23.0 mg/dL, p=0.0016) at 24 weeks. Treatment with saxagliptin resulted in similar reductions in HBA(1c) relative to placebo, irrespective of metformin treatment. At 24 weeks, difference in adjusted mean fasting plasma glucose for saxagliptin versus placebo was -4.02 mg/dL (p=0.3958); 17.3% and 6.7% of patients in the saxagliptin and placebo groups, respectively, achieved HbA(1c) <7%. Mean change from baseline in body weight at week 24 was 0.39 kg for saxagliptin and 0.18 kg for placebo. Hypoglycaemia was reported in 18.4% and 19.9% of patients in the saxagliptin and placebo groups, respectively (confirmed hypoglycaemia: 5.3%, 3.3%). Other adverse events reported in at least 5% of patients were urinary tract infection (saxagliptin, placebo: 5.9%, 6.0%), influenza (3.0%, 6.6%), and pain in extremity (1.6%, 6.0%). Conclusions: Saxagliptin 5-mg once-daily add-on therapy improves glycaemic control in T2D patients on insulin alone or combined with metformin and is generally well tolerated. |
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Authors:
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Anthony H Barnett; Bernard Charbonnel; Mark Donovan; Douglas Fleming; Roland Chen; |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-2-8 |
Journal Detail:
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Title: Current medical research and opinion Volume: - ISSN: 1473-4877 ISO Abbreviation: - Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-2-8 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0351014 Medline TA: Curr Med Res Opin Country: - |
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Languages: ENG Pagination: - Citation Subset: - |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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