Multicenter, open-label, nonrandomized, observational safety study in subjects using insulin aspart in basal-bolus regimen for the treatment of diabetes.

Abstract

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.

• Authors: Janusz Krzymień, Teresa Kobli, Maciej Nazar
• Journal: Polskie Archiwum Medycyny Wewnetrznej (Pol Arch Med Wewn) Vol. 120 Issue 11 Pg. 444-50 (Nov 2010) Poland
• PMID: 21102380 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Insulin Aspart

Topics

• Adolescent
• Adult
• Aged
• Blood Glucose (analysis)
• Comorbidity
• Diabetes Mellitus, Type 1 (drug therapy, epidemiology)
• Diabetes Mellitus, Type 2 (drug therapy, epidemiology)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (chemically induced, epidemiology)
• Hypoglycemic Agents (administration & dosage, adverse effects)
• Incidence
• Insulin (administration & dosage, adverse effects, analogs & derivatives)
• Insulin Aspart
• Male
• Middle Aged
• Poland (epidemiology)
• Treatment Outcome
• Young Adult