Safety and effectiveness of insulin analogues in Moroccan patients with type 2 diabetes: a sub-analysis of the A₁chieve study.

Abstract

AIM:

To determine the safety and effectiveness of insulin analogues in the Moroccan cohort of the prospective, multinational, non-interventional, 24-week A₁chieve study.

METHODS:

Moroccan patients with type 2 diabetes (T2D) starting biphasic insulin aspart 30, insulin detemir, and insulin aspart alone or in combination were included. The primary outcome was the evaluation of serious adverse drug reactions including major hypoglycaemic events. Secondary outcomes were changes in hypoglycaemic events, glycaemic parameters (HbA1c, fasting plasma glucose [FPG], postprandial plasma glucose [PPPG]), systolic blood pressure (SBP), body weight and lipid profile. Quality of life (QoL) was evaluated using the EQ-5D questionnaire.

RESULTS:

In this analysis, 1641 patients (923 insulin-naive, 718 insulin-experienced) having a mean age 57.1 years, mean BMI 26.8 kg/m(2) and mean diabetes duration 10.3 years, were included. Baseline HbA1c in the entire cohort was poor (9.7%, 83 mmol/mol). Insulin analogues statistically significantly improved glucose control (HbA1c, FPG and PPPG, p < 0.001) at Week 24. The rate of hypoglycaemia decreased from 9.31 to 4.71 events/patient-year (change in proportion of patients affected, p = 0.0002). A statistically significant improvement in lipid parameters (except HDL cholesterol) was observed while body weight changed minimally. Additionally, QoL was positively impacted (mean change in visual analogue scores from EQ-5D was 15.8 points, p < 0.001).

CONCLUSIONS:

Insulin analogue therapy resulted in improved glycaemic control and a significant overall decrease in hypoglycaemia in Moroccan T2D patients.

• Authors: Abdelmjid Chraibi, Farida Ajdi, Jamal Belkhadir, Naoual El Ansari, Fatima Marouan, Ahmed Farouqi
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 101 Suppl 1 Pg. S27-36 (Aug 2013) ISSN: 1872-8227 [Electronic] Ireland
• PMID: 23958569 (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
• hemoglobin A1c protein, human
• Insulin Detemir
• Insulin Aspart

Topics

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