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Insulin detemir in the management of type 2 diabetes in non-Western countries: Safety and effectiveness data from the A1chieve observational study

Alexey Zilov, Nabil El Naggar, Siddharth Shah, Chunduo Shen and Jihad Haddad

Diabetes Research and Clinical Practice, 3, 101, pages 317 - 325

Received 24 December 2012, Revised 16 May 2013, Accepted 6 June 2013, Published online Oct-2013


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2. Methods

2.1. Study design

A1chieve was a 24-week, international, prospective, multicentre, non-interventional study of people with T2D who had started using basal insulin detemir, bolus insulin aspart or biphasic insulin aspart 30 alone or in combination, to evaluate their safety and effectiveness in routine clinical practice [7] and [21] 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 Abstract, Full-text, PDF, Crossref. x Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract 2010; 88(Suppl 1):S11-6. . The study was carried out in 28 countries across Asia, Africa, Latin America and Europe, grouped into seven geographical regions: China, South Asia, East Asia, North Africa, Middle East/Gulf, Latin America and Russia. A total of 66,726 people participated in the study from 3166 clinical sites, recruited between January 2009 and June 2010.

2.2. Participants and treatment

Clinical outcomes are reported here for people with T2D who were prescribed insulin detemir by their physician in the course of normal clinical practice. They were eligible for enrolment provided prior pharmaceutical therapy did not include exposure to the study insulins for >4 weeks prior to acceptance. Patients with a hypersensitivity to the study drug or the excipients, and women who were pregnant, breastfeeding, or had the intention of becoming pregnant within the next 24 weeks were excluded from the study. When prescribed, insulin detemir was commercially available and was funded according to local practice in routine care. The selection of patients and any changes to dose and concomitant therapy were made at the discretion of the participant and consulting physician. Ethical approval was obtained in each country.

2.3. Assessments and outcome measures

The primary safety assessment was evaluation of the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to insulin detemir between baseline and final visit. Secondary safety assessments included the change in number of hypoglycaemic events in the last 4 weeks before the interim and final visits (approximately 12 and 24 weeks from baseline), compared with the last 4 weeks before the baseline visit, and the number of adverse drug reactions (ADRs) from baseline to final visit.

Effectiveness assessments were change in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight between baseline and interim and final visits, and change in systolic blood pressure (SBP) and lipid profile at final visit. Assessments were recorded by physicians during routine clinical visits and data were collected from medical records, patient diaries, and recall, and laboratory measurements were made in local laboratories. The physician's rationale for prescribing insulin detemir was also recorded.

Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [22] x EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199-208 at baseline and after 24 weeks of therapy. This questionnaire was designed to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and provides a visual analogue scale (VAS) for individuals to rate their current HRQoL between 0 and 100, with a higher score indicating better self-perceived health. Full study design details, assessments, and outcome measures have been published previously [7] 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 Abstract, Full-text, PDF, Crossref. .

2.4. Statistical methods

Analysis of safety and efficacy outcomes was performed on any participant entered into the study who had data relevant to that analysis. Analyses were performed for the entire cohort prescribed insulin detemir, categorised by prior insulin-treated or insulin-naïve and by geographical regions (defined in study design). Comparison between pre-study therapy and regions are reported as descriptive statistics only. Changes from baseline for HbA1c, FPG, PPG, lipids, and QoL were analysed using a paired t-test, with the majority of data expressed as mean (standard deviation [SD]), unless otherwise stated. Due to the low number of participants in this sub-group analysis from China, descriptive data only are presented in the tables to represent the entire regional profile. For hypoglycaemia change from baseline, the percentage of people reporting at least one event was analysed using McNemar's test.

References

Label Authors Title Source Year
[7]

References in context

  • Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [22] at baseline and after 24 weeks of therapy.
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  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
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  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
    Go to context

  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
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  • Regionally, both the poor level of glycaemic control at baseline and the magnitude of improvement were remarkably consistent.
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  • Interestingly, in the entire A1chieve study population, although no clinically significant weight change was reported, a larger range was seen (−0.8 and +0.9kg) [7].
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  • Interestingly, in the entire A1chieve study population, although no clinically significant weight change was reported, a larger range was seen (−0.8 and +0.9kg) [7].
    Go to context

  • The A1chieve study, by nature of its design, has a number of limitations that must be considered when interpreting the data [7].
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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 Abstract, Full-text, PDF, Crossref. Diabetes Res Clin Pract. 2011;94:352-363 2011
[22]

References in context

  • Table entry: −2.0 (1.6) [22]
    Go to context

  • Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [22] at baseline and after 24 weeks of therapy.
    Go to context

EuroQol Group EuroQol – a new facility for the measurement of health-related quality of life Health Policy. 1990;16:199-208 1990

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