, Volume 4, Issue 2, pp 347-361,
Open Access This content is freely available online to anyone, anywhere at any time.
Date: 17 Jul 2013

Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis

Abstract

Introduction

Effective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40–65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes.

Methods

A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups.

Results

Data on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40–65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from −1.8% to −2.4%); fasting plasma glucose (from −3.0 to −4.3 mmol/l); post-breakfast post-prandial plasma glucose (from −4.1 to −6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported.

Conclusion

After 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

This trial was registered with ClinicalTrials.gov (NCT00869908).