Introduction: This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart [with/without oral glucose-lowering drugs (OGLDs)] as the only insulin therapy.
Methods: A1chieve was an international, multicenter, prospective, open-label, non-interventional, observational, 24-week study in people with type 2 diabetes mellitus starting/switching to biphasic insulin aspart 30, insulin detemir or insulin aspart treatment (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart (±OGLDs) as the only insulin therapy. Data were analyzed for all patients, insulin-experienced and insulin-naive sub-groups, and sub-groups defined by the number of OGLDs prescribed at baseline (no OGLDs, one OGLD or ≥two OGLDs). Safety and effectiveness endpoints were assessed at baseline and following 24 weeks' therapy.
Results: In total, 2,026 patients were included (insulin-experienced, n = 561; insulin-naive, n = 1,465) in this sub-analysis. Significant improvements from baseline after 24 weeks' treatment with insulin aspart ± OGLDs were observed across all sub-groups for: glycated hemoglobin (range of means across sub-groups -1.6 to -2.4%; p < 0.001 for all comparisons), fasting plasma glucose (-2.5 to -3.8 mmol/l; p < 0.001 for all comparisons), post-breakfast post-prandial glucose (-3.4 to -5.8 mmol/l; p < 0.001 for all comparisons), and health-related quality of life (HRQoL; p < 0.001 for all comparisons). The proportion of patients reporting hypoglycemia events was significantly reduced from baseline after 24 weeks (insulin-naive cohort: 7.9-2.8%; p < 0.001; insulin-experienced cohort: 23.2-7.8%; p < 0.001). There were no reports of major hypoglycemia events at 24 weeks; risk of nocturnal hypoglycemia was <0.6 events/person-year. No serious adverse drug reactions were reported.
Conclusion: Insulin aspart ± OGLDs is associated with significant improvements in glycemic control and HRQoL, without increased risk of hypoglycemia, in people with type 2 diabetes and sub-optimal glucose control.