Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis
- Mohammad Ebrahim KhamsehAffiliated withEndocrine Research Centre (Firouzgar), Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences
- , Jihad HaddadAffiliated withEndocrinology Section, Department of Internal Medicine, Prince Hamzah Hospital
- , Wenying YangAffiliated withChina-Japan Friendship Hospital
- , Alexey ZilovAffiliated withDepartment of Endocrinology, First Moscow State Medical University
- , Ole Molskov BechAffiliated withNovo Nordisk Saglik Ürünleri Tic. Ltd. Sti. Email author
- , Mohammad Imtiaz HasanAffiliated withDiabetics’ Institute Pakistan
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.
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.
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.
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.
KeywordsBiphasic insulin aspart Non-interventional study Observational study Type 2 diabetes
- Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
Volume 4, Issue 2 , pp 347-361
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- Biphasic insulin aspart
- Non-interventional study
- Observational study
- Type 2 diabetes
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- Author Affiliations
- 1. Endocrine Research Centre (Firouzgar), Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences, Tehran, Iran
- 2. Endocrinology Section, Department of Internal Medicine, Prince Hamzah Hospital, Amman, Jordan
- 3. China-Japan Friendship Hospital, Beijing, China
- 4. Department of Endocrinology, First Moscow State Medical University, Moscow, Russia
- 5. Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti., Istanbul, Turkey
- 6. Diabetics’ Institute Pakistan, Lahore, Pakistan