Dataset Information

Safety, tolerability, and efficacy of insulin aspart in people with type 2 diabetes, as biphasic insulin aspart or with Basal insulin: findings from the multinational, non-interventional a1chieve study.

ABSTRACT:

Introduction

The aim of the study was to investigate the clinical safety and effectiveness of starting insulin aspart (aspart) therapy in people with type 2 diabetes mellitus (T2DM) as a sub-analysis of the multinational, non-interventional A1chieve study.

Methods

Insulin-naïve and insulin-experienced people with T2DM in routine clinical care starting aspart alone at baseline and continuing aspart alone, changing to biphasic insulin aspart 30 (aspart premix) or adding a basal insulin by study end, were included. Safety, tolerability, and efficacy were evaluated over 24 weeks.

Results

Overall, 3,898 people started aspart at baseline. Of the 3,313 with 24-week data, 1,545 (46.6%) continued with aspart, 1,379 (41.6%) switched to aspart premix, and 214 (6.5%) added basal insulin, while the remainder switched to other regimens. No serious adverse drug reactions were reported. The proportion of participants reporting hypoglycemia decreased from baseline to week 24 in the aspart alone group (11.2% versus 4.1%, p < 0.001) and in the aspart + basal insulin group (13.1% versus 7.5%, p = 0.040), and was 3.7% at week 24 in the aspart premix group. The mean HbA1c decreased from baseline to week 24 (aspart: -2.1 ± 2.0% [-23 ± 22 mmol/mol], aspart premix: -2.3 ± 1.7% [-25 ± 19 mmol/mol], aspart + basal insulin: -2.0 ± 2.1% [-22 ± 23 mmol/mol]; p < 0.001).

Conclusion

Insulin aspart therapy was well tolerated and was associated with improved glucose control over 24 weeks in people with T2DM.

SUBMITTER: Hajjaji I

PROVIDER: S-EPMC4065304 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionEffective 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.MethodsA1chieve 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.ResultsData 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.ConclusionAfter 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.

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