Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A₁chieve study.

Abstract

AIMS:

This A1chieve® study subgroup analysis examined clinical safety and effectiveness of biphasic insulin aspart 30 (BIAsp30) ±OGLDs in 6323 individuals with T2D, switching from biphasic human insulin 30 (BHI30) ±OGLDs.

METHODS:

A1chieve was a 24-week, international, prospective, observational, multi-centre, open-label study in individuals with T2D starting treatment with BIAsp30, insulin detemir or insulin aspart as part of routine clinical care.

RESULTS:

Mean baseline (SD) dose BHI was 0.56 (0.25) IU/kg. BIAsp30 was initiated at 0.57 (0.25) U/kg; the daily dose was 0.62 (0.28)U/kg by Week 24. Switching from BHI30 to BIAsp30 was associated with significant mean reduction in HbA1c of 1.7% [-18 mmol/mol] (1.6) from a baseline of 9.1% [76 mmol/mol] (p<0.001); FPG and PPG were also significantly reduced (p<0.001). Major hypoglycaemic episodes decreased from 0.69 events/patient/year at baseline to 0.03 events/patient/year at Week 24. Minor hypoglycaemia decreased from 5.31 to 2.04 events/patient/year from baseline to study-end. Five serious adverse drug reactions (hypoglycaemia) were reported by five individuals (0.1%). Mean bodyweight increased by 0.1 (3.3)kg from baseline to 24 weeks. Improved self-reported quality of life was observed.

CONCLUSION:

Switching from BHI30 to BIAsp30 in individuals with T2D is associated with improvement in glycaemic control and reduced rates of hypoglycaemia, without tolerability or safety issues.

• Authors: Nabil K El Naggar, Pradana Soewondo, Mohammad E Khamseh, Jian-Wen Chen, Jihad Haddad
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 98 Issue 3 Pg. 408-13 (Dec 2012) ISSN: 1872-8227 [Electronic] Ireland
• PMID: 23217267 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Chemical References

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

Topics

• Adult
• Africa, Northern
• Aged
• Asia
• Biphasic Insulins (adverse effects, therapeutic use)
• Cohort Studies
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Drug Combinations
• Drug Monitoring
• Female
• Glycated Hemoglobin
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (prevention & control)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Insulin Aspart (adverse effects, therapeutic use)
• Insulin, Isophane (adverse effects, therapeutic use)
• Male
• Middle Aged
• Middle East
• Prospective Studies
• Quality of Life