Exploring insulin analogue safety and effectiveness in a Maghrebian cohort with type 2 diabetes: results from the A₁chieve study.

Abstract

AIM:

To evaluate the safety and effectiveness of insulin analogues in patients with type 2 diabetes (T2D) from Morocco, Algeria and Tunisia that formed the Maghrebian cohort of the 24-week, non-interventional A₁chieve study.

METHODS:

Patients starting biphasic insulin aspart, insulin detemir and insulin aspart, alone or in combination, were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary outcomes included hypoglycaemia, glycated haemoglobin A₁c (HbA₁c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), systolic blood pressure (SBP), body weight and lipids. Quality of life (QoL) was evaluated using the EQ-5D questionnaire.

RESULTS:

Overall, 3720 patients with a mean age of 58.6 years, body mass index of 27.7 kg/m(2) and diabetes duration of 11.5 years were enrolled. Pre-study, insulin-experienced patients had a mean ± SD dose of 0.54 ± 0.27 U/kg. In the entire cohort, the mean dose was 0.42 ± 0.27 U/kg at baseline, titrated to 0.55 ± 0.30 U/kg by Week 24. Twenty-six SADRs were reported during the study. There was a significant decrease in the proportion of patients reporting overall hypoglycaemia from baseline to Week 24 (18.3% to 13.8%, p < 0.0001). The mean HbA₁c improved significantly from 9.5 ± 1.8% to 7.9 ± 1.4% (p < 0.001). The mean FPG, PPPG, SBP, total cholesterol and QoL also improved significantly (all p < 0.001), while the mean body weight increased by 0.9 ± 3.9 kg (p < 0.001).

CONCLUSION:

Insulin analogue therapy was well-tolerated and was associated with improved glycaemic control.

• Authors: Mohamed Belhadj, Amine Dahaoui, Henda Jamoussi, Ahmed Farouqi
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 101 Suppl 1 Pg. S4-14 (Aug 2013) ISSN: 1872-8227 [Electronic] Ireland
• PMID: 23958571 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Biomarkers
• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin, Long-Acting
• Lipids
• hemoglobin A1c protein, human
• Insulin Detemir
• Insulin Aspart

Topics

• Algeria (epidemiology)
• Asian People
• Biomarkers (blood)
• Blood Glucose (metabolism)
• Diabetes Mellitus, Type 2 (blood, drug therapy, epidemiology)
• Drug Therapy, Combination
• Drug-Related Side Effects and Adverse Reactions
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hypoglycemia (epidemiology)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Insulin Aspart (administration & dosage, adverse effects, therapeutic use)
• Insulin Detemir
• Insulin, Long-Acting (administration & dosage, adverse effects, therapeutic use)
• Lipids (blood)
• Male
• Middle Aged
• Morocco (epidemiology)
• Postprandial Period
• Prospective Studies
• Quality of Life
• Risk Factors
• Surveys and Questionnaires
• Treatment Outcome
• Tunisia (epidemiology)
• Weight Gain