The IMPROVE study--a multinational, multicentre, observational study in type 2 diabetes: results from the Italian cohort

Acta Biomed. 2010 Sep;81(2):115-24.

Abstract

Aims: The IMPROVE study evaluated the safety and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in type 2 diabetes patients in the routine practice. Here we present the results for patients from Italy.

Methods: Adverse events, hypoglycaemia, glycaemic control, patient treatment satisfaction and physician resource utilisation were assessed at baseline and 26 weeks.

Results: Out of the 1371 patients enrolled, 84.1% (n=1153) were receiving BIAsp 30 at baseline (in accordance with local regulations), and were included in the study. Mean HlbA, reduction was--0.63% after 26 weeks (p < 0.001); 26.5% and 13.5% of patients reached the HbA(1c) targets of < 7% and < 6.5%, respectively. Fasting and postprandial blood glucose significantly decreased; 65% of patients were using BIAsp 30 once daily and 32% twice daily at final visit. Rates of major and minor hypoglycaemic events also significantly decreased. Small weight increase was observed, and total insulin daily dose increased from 0.29 IU/kg pre-study to 0.32 IU/kg at final visit.

Conclusions: In Italy, BIAsp 30 in the routine care improved glycaemic control and reduced hypoglycaemia; however, there was little intensification and titration. This may partly explain the relatively small improvement in glycaemic control in Italy compared with other countries in the IMPROVE study.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biphasic Insulins
  • Cohort Studies
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Female
  • Glycated Hemoglobin / metabolism
  • Humans
  • Hyperglycemia / drug therapy
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Insulin / administration & dosage
  • Insulin / adverse effects
  • Insulin / analogs & derivatives*
  • Insulin Aspart
  • Insulin, Isophane
  • International Cooperation
  • Italy
  • Male
  • Middle Aged
  • Patient Satisfaction

Substances

  • Biphasic Insulins
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • hemoglobin A1c protein, human
  • insulin aspart, insulin aspart protamine drug combination 30:70
  • Insulin, Isophane
  • Insulin Aspart