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Multicenter, open-label, non-randomized, non-interventional observational study of safety of treatment initiation with a biphasic insulin aspart.
MedLine Citation:
PMID:  23289795     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: Type 2 diabetes mellitus is characterized by hyperglycaemia. Incidence and progression of microvascular complications have been shown to undergo reduction with lowered glucose levels. Methods: This is an open-label, non-randomized, non-interventional, observational study of safety and efficacy of BiAsp 30, enrolling 2223 patients with type 2 diabetes mellitus. Patients previously treated with oral antidiabetic drugs and/or human insulin were recruited, provided they had been hospitalized for at least 3 days. Data were collected during a single multi-stage visit lasting up to 6 days, during the patient's hospitalization period. A mild hypoglycaemic episode was defined as blood glucose measurement < 56 mg/dL (3.1 mmol/L). A severe hypoglycaemia was hypoglycaemic episode requiring assistance of another person. Results: The total number of hypoglycaemic episodes decreased over time of follow-up. The intensity of severe hypoglycaemic episodes decreased by almost a third from day to day (IRR = 0.64, 95%, p < 0.001). However, intensity of mild hypoglycaemic episodes was the same over the subsequent days of follow-up (IRR = 0.97, p > 0.1). Mean blood glucose concentration decreased from 202.0 mg/dL to 157.8 mg/dL after 3 days and to 138.3 mg/dL after 6 days (p < 0.001). Conclusion: This study highlights the safety, efficacy and ease of initiation of insulin BiAsp 30 therapy for treatment of type 2 diabetes mellitus.
Authors:
Bogumił Wolnik; Lukasz Hak
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-7
Journal Detail:
Title:  Expert opinion on drug safety     Volume:  -     ISSN:  1744-764X     ISO Abbreviation:  Expert Opin Drug Saf     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101163027     Medline TA:  Expert Opin Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Medical University of Gdańsk, Department of Hypertension and Diabetology , Debinki 7, 80-211 Gdansk , Poland bwolnik@gumed.edu.pl.
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