Multicenter, open-label, non-randomized, non-interventional observational study of safety of treatment initiation with a biphasic insulin aspart.

Abstract

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
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 12 Issue 2 Pg. 137-44 (Mar 2013) ISSN: 1744-764X [Electronic] England
• PMID: 23289795 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Biphasic Insulins
• Blood Glucose
• Hypoglycemic Agents
• insulin aspart, insulin aspart protamine drug combination 30:70
• Insulin, Isophane
• Insulin Aspart

Topics

• Biphasic Insulins (adverse effects, therapeutic use)
• Blood Glucose (drug effects)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Female
• Follow-Up Studies
• Hospitalization (trends)
• Humans
• Hypoglycemia (blood, chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Insulin Aspart (adverse effects, therapeutic use)
• Insulin, Isophane (adverse effects, therapeutic use)
• Male
• Treatment Outcome