| Multicenter, open-label, nonrandomized, observational safety study in subjects using insulin aspart in basal-bolus regimen for the treatment of diabetes. | |
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MedLine Citation:
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PMID: 21102380 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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INTRODUCTION: Basal-bolus insulin therapy is a standard method of intensifying diabetes treatment. A common adverse effect of such treatment is hypoglycemia. Data on frequency of hypoglycemia when fast-acting insulin analogue is used in everyday clinical practice is scarce. OBJECTIVES: The aim of the study was to investigate the risk of hypoglycemia after the use of insulin aspart in basal-bolus therapy in patients with type 1 and 2 diabetes. PATIENTS AND METHODS: It was a multicenter, open-label, noninterventional study. It involved 950 patients with type 1 and 1332 patients with type 2 diabetes who started preprandial insulin aspart in basal-bolus regimen. Patients were followed for 13 weeks. The primary endpoint was the incidence of major daytime and nocturnal hypoglycemic events assessed on the basis of patients' self-reports during follow-up compared with a 4-week period before the baseline visit. Secondary endpoints were: incidence of minor daytime and nocturnal hypoglycemia, hemoglobin A1c (HbA1c), fasting and postprandial glycemia. RESULTS: The rate of major hypoglycemia decreased in patients with type 1 diabetes--the incidence rate ratio (IRR) was 0.14 for daytime and 0.03 for nocturnal episodes (P <0.0001) and did not change in patients with type 2 diabetes. The rate of minor episodes decreased in patients with type 1 diabetes (IRR = 0.44 for daytime and IRR = 0.24 for nocturnal episodes, P <0.0001) and in patients with type 2 diabetes (IRR= 0.57, P <0.0001 for daytime and IRR = 0.89, P <0.05 for nocturnal episodes). HbA1c decreased by 1.28 ± 1.64% in type 1 and 1.25 ± 1.10% in type 2 diabetes (both P <0.0001). Self-measured fasting and postprandial blood glucose levels were significantly lower at the final visit compared with baseline, irrespective of diabetes type. CONCLUSIONS: In clinical practice, treatment with insulin aspart in basal-bolus regimen is associated with low risk of hypoglycemia and leads to a significant improvement in glucose control, irrespective of diabetes type. |
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Authors:
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Janusz Krzymień; Teresa Kobli; Maciej Nazar |
Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Polskie Archiwum Medycyny Wewnętrznej Volume: 120 ISSN: 1897-9483 ISO Abbreviation: Pol. Arch. Med. Wewn. Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-11-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0401225 Medline TA: Pol Arch Med Wewn Country: Poland |
Other Details:
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Languages: eng Pagination: 444-50 Citation Subset: IM |
Affiliation:
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Department of Gastroenterology and Metabolic Diseases, Medical University of Warsaw, Warszawa, Poland. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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