Background: The A1chieve study evaluated safety and effectiveness of insulin analogues in a large and diverse population. This report presents a subgroup analysis of the A1chieve observational study pertaining to India.
Objective: To assess safety and effectiveness of initiation or intensification of insulin detemir in patients with type 2 diabetes mellitus (T2DM) not achieving adequate glycemic control.
Methods: The A1chieve study was a prospective, multi-center, open-label, non-interventional study of 24-weeks duration. In this post-hoc analysis, Indian patients with T2DM who did not achieve their glycemic targets, and were started with or switched to insulin detemir, were evaluated at baseline and after 24 weeks of therapy for safety and effectiveness. Adverse events (AE) noted during the course of therapy were recorded. Additionally Glycemic, non-glycemic parameters and quality of life indices were reported. Appropriate statistical analysis was carried out to assess the statistical significance.
Results: The Indian cohort of 2707 patients with T2DM treated with insulin detemir included 2336 (86.29%) insulin-naive and 371 (13.71%) insulin-experienced patients. No adverse drug reaction (ADR) was noted over 24 weeks, one patient (out of 2707) reported serious adverse event. Major hypoglycemia was reported in 0.5% (0.08 events/patient year) patients and reduced to 0% (0 events/patient year) over 24 weeks. After 24 weeks' treatment with insulin detemir, an overall reduction in HbA(1c) of 2.1% was noted (p < 0.001), with a 2.1% (p < 0.001) and 2% (p < 0.001) reduction in insulin-naive and insulin-experienced groups, respectively. A significant reduction in fasting ([mean +/- SD] -3.8 +/- 2.5 mmol/L) and postprandial (-5.2 +/- 3.9 mmol/L) blood glucose (FPG and PPG) was also observed (p < 0.001 for both). At end of the study, 24.4% patients achieved the ADA target of < 7.0% and 14.3% patients achieved the AACE target of < 6.5% for HbA(1c). A significant improvement in quality of life indices like ED-5D (0.31 +/- 0.29; p < 0.001) and EQ-VAS (21.7 +/- 16.7; p < 0.001) was noticed.
Conclusion: In patients with T2DM not achieving their glycemic targets addition of basal insulin detemir was well tolerated and reported improvement in glycemic control.