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Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: Results from the A1chieve study

Nabil K. El Naggar, Pradana Soewondo, Mohammad E. Khamseh, Jian-Wen Chen and Jihad Haddad

Diabetes Research and Clinical Practice, 3, 98, pages 408 - 413

Published online Dec-2012


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2. Materials and methods

2.1. Study design

The A1chieve® study was an international prospective, obser vational, multicentre, open label, non-interventional, 24-week study in people with T2D who were treatment naïve or who had been using anti-diabetic medication other than Novo Nordisk insulin analogues being evaluated and who had started treatment with BIAsp 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice [8] x P. Home, N.E. Naggar, M. Khamseh, G. Gonzalez-Galvez, C. Shen, P. Chakkarwar, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res. Clin. Pract.. 2011;94:352-363 . This subgroup analysis examined the effects of switching from BHI 30 to BIAsp 30.

2.2. Setting

The A1chieve® study was performed in 28 countries in seven regions (China, South Asia, East Asia, North Africa, Middle East/Gulf, Latin America and Russia) between November 2008 and March 2011. This manuscript reports overall data and individual regional data for five of the seven regions.

2.3. Participants

Patient selection was at the discretion of the individual physician. After the physician had taken the decision to use BIAsp 30, insulin detemir or insulin aspart (alone or in combination), any patient with T2D who was not treated with the insulin analogues being evaluated (or who had started on these insulin analogues within the last 4 weeks before inclusion into this study) was eligible for the study. Individuals who had a hypersensitivity to the insulin analogues being evaluated and women who were pregnant, lactating or had the intention of becoming pregnant within the next 6 months were excluded. Ethics committee approval was gained in each country. Each participant provided written informed consent.

2.4. Variables

The efficacy variables included changes in HbA1c, FBG and PPG at Weeks 12 and 24 compared with baseline. Change in quality of life (QoL) from baseline to Week 24 was also examined.

The primary safety variable was the number of serious adverse drug reactions (SADRs) including major hypoglycaemic events from baseline to final visit. Secondary safety variables included change in number of hypoglycaemic events and nocturnal hypoglycaemic events in the 4 weeks prior to the interim and final visit compared with the 4 weeks prior to the baseline visit; the number of adverse drug reactions (ADRs) from baseline to final visit; and change in body weight at Weeks 12 and 24 compared to baseline. Other secondary safety assessments were adverse events (AEs), and change in lipids and creatinine at Week 24 compared with baseline.

2.5. Data sources/measurement

The most recent measurements taken during the 4 weeks prior to each visit were recorded for HbA1c, FPG and PPG values at baseline, Week 12 and Week 24. ADRs and serious AEs (SAEs) were collected and reported. At each contact with their physician (visit or telephone), participants were questioned about ADRs and a case report form was completed whenever an event was reported. Participants were asked to complete the EQ-5D questionnaire, a validated tool used to assess QoL at baseline and Week 24. The questionnaire covered five areas: mobility, self care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D questionnaire also enabled individuals to rank their QoL based on a visual analogue scale (0–100) where 100 corresponds to the highest QoL.

2.6. Study size

Physicians could choose to start individuals on BIAsp 30, insulin detemir or insulin aspart alone or in combination. Assuming an equal distribution of people amongst these insulins, a sample size of 60,000 people was calculated to be sufficient to detect an SADR with an incidence of 0.015%.

2.7. Statistical methods

Changes from baseline for HbA1c, FPG, PPG, lipids and QoL were analysed using a paired t-test. For the purposes of this publication the cut-off for reporting individual regional data was set at <100 people. Therefore, data for Latin America (40 individuals) and Russia (86 individuals) are not reported individually, but data from these patients are included in the overall cohort. The majority of data are expressed as mean (standard deviation [SD]) unless otherwise stated.

References

Label Authors Title Source Year
[8]

References in context

  • It is important to select insulin therapy according to individual needs and the A1chieve® study is the first observational study that included individuals who were switched to BIAsp 30, insulin detemir (Levemir®, Novo Nordisk) or insulin aspart (NovoRapid®, Novo Nordisk) alone or in combination as part of their routine clinical care [8].
    Go to context

  • The A1chieve® study was an international prospective, obser vational, multicentre, open label, non-interventional, 24-week study in people with T2D who were treatment naïve or who had been using anti-diabetic medication other than Novo Nordisk insulin analogues being evaluated and who had started treatment with BIAsp 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice [8].
    Go to context

  • This hypothesis was supported by the overall A1chieve® data, which showed minimal body weight gain in association with improved HbA1c, as well as improved blood pressure and lipid profile [8].
    Go to context

P. Home, N.E. Naggar, M. Khamseh, G. Gonzalez-Galvez, C. Shen, P. Chakkarwar, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study Diabetes Res. Clin. Pract.. 2011;94:352-363 2011

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