Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis

Abstract

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.

Figures

Fig. 1

Mean (SD) insulin dose received by patients at baseline and after 24 weeks on insulin aspart therapy in the A1chieve study. Due to the observational nature of the study not all measures were reported/collected. At baseline: insulin-experienced: n = 257 in 0 OGLD sub-group; n = 182 in 1 OGLD sub-group; n = 86 in ≥2 OGLDs sub-group. Insulin-naive: n = 477 in 0 OGLD sub-group; n = 536 in 1 OGLD sub-group; n = 373 in ≥2 OGLDs sub-group. After 24 weeks: insulin-experienced: n = 178 in 0 OGLD sub-group; n = 138 in 1 OGLD sub-group; n = 64 in ≥2 OGLDs sub-group. Insulin-naive: n = 326 in 0 OGLD sub-group; n = 422 in 1 OGLD sub-group; n = 274 in ≥2 OGLDs sub-group. OGLD oral glucose-lowering drug