Safety and effectiveness of insulin detemir in different age-groups in the A1chieve study

Abstract

Introduction: Diabetes therapy should balance glycemic control with risk of adverse events. This sub-analysis of the A1chieve study evaluated clinical safety and effectiveness of insulin detemir in different age-groups (B40 years, [40-65 years, and [65 years) of insulin-experienced and insulin-nai{dotless}̈ve people with type 2 diabetes. Methods: A1chieve was an international, openlabel, non-interventional, 24-week study in 66,726 people with type 2 diabetes starting/ switching to therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness in patients starting/ switching to insulin detemir (±oral glucoselowering drugs). Results: In total, 15,241 patients were included in the sub-analysis. In all age-groups, the proportion of participants experiencing any, major or nocturnal hypoglycemia was significantly (all p\0.05) reduced relative to baseline, except in insulin-naïve patients for any and nocturnal hypoglycemia, where there was a significant increase or no significant change in patients aged [65 years and [40-65 years, respectively, and no significant change in major hypoglycemia in insulin-nai{dotless}̈ve patients aged B40 years. Seven serious adverse drug reactions were reported. Body weight was significantly reduced in patients aged B40 years and[40-65 years and significantly increased in insulin-naïve patients aged [65 years at 24 weeks. At 24 weeks, glycated hemoglobin was reduced by 2.3%, 2.0%, and 1.8%, in the B40 years, [40-65 years, and [65 years agegroups, respectively (all p\0.001). Fasting and post-prandial plasma glucose were significantly reduced and health-related quality of life (HRQoL) significantly improved across all patient cohorts (all p\0.001). Conclusion: After 24-week treatment with insulin detemir, all age-groups of insulinexperienced and insulin-naïve patients had significantly improved glycemic control and HRQoL. The proportion of patients experiencing hypoglycemia was reduced in all age-groups but unchanged in insulin-naïve patients aged[40-65 years and increased in insulin-naïve patients aged [65 years. The safety and effectiveness of insulin detemir may benefit all age-groups. © The Author(s) 2013.