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Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study.

ABSTRACT: IMPROVE is an open-label, multinational, non-randomised, 26-week observational study designed to evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in routine clinical practice. Here, we report data for patients switching to BIAsp 30 from human premixed insulin.Patients (n = 3856) with type 2 diabetes previously receiving human premixed insulin with or without oral antidiabetic drugs were eligible for inclusion. Demographic data, efficacy end-points (HbA(1c), fasting blood glucose and postprandial blood glucose) and safety end-points (serious adverse drug reactions, hypoglycaemia and adverse events) were collected at baseline and final visit. A subgroup analysis of mean dose change was also undertaken.Switching patients to BIAsp 30 resulted in significant improvements in glycaemic control combined with a reduced risk of hypoglycaemia. Patients who reached the HbA(1c) target (< 7%) had shorter diabetes duration, lower HbA(1c) at baseline and needed less insulin. Over 30% of patients were able to reach this target without experiencing hypoglycaemia over the 26-week period. Compared with asymmetric dose switching, unit-for-unit switching resulted in the highest proportion of patients reaching HbA(1c) target and incurred the least amount of dose titration.A unit-for-unit switch is the most effective as well as the simplest approach when transferring patients from biphasic human insulin 30 to BIAsp 30.

SUBMITTER: Shah S

PROVIDER: S-EPMC2705824 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study.

Shah S S Benroubi M M Borzi V V Gumprecht J J Kawamori R R Shaban J J Shestakova M M Wenying Y Y Valensi P P

International journal of clinical practice 20090205 4

<h4>Aims</h4>IMPROVE is an open-label, multinational, non-randomised, 26-week observational study designed to evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in routine clinical practice. Here, we report data for patients switching to BIAsp 30 from human premixed insulin.<h4>Methods</h4>Patients (n = 3856) with type 2 diabetes previously receiving human premixed insulin with or without oral antidiabetic drugs were eligible for inclusion. Demographic data, efficacy ...[more]

PMID: 19210701

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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.

Dataset Information

Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study.

Publications

Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study.

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