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The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: Results from the A1chieve observational study

Philip D. Home, Zafar A. Latif, Guillermo González-Gálvez, Vinay Prusty and Zanariah Hussein

Diabetes Research and Clinical Practice, 3, 101, pages 326 - 332

Received 3 January 2013, Revised 15 May 2013, Accepted 6 June 2013, Published online Oct-2013


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3. Materials and methods

3.1. Study design

The A1chieve study was a 24-week, prospective, international, non-interventional observational study, conducted in 3166 centres across 28 countries in four continents other than Western Europe and North America. Eligible participants were insulin-naïve or prior insulin users with type 2 diabetes starting or switching to basal insulin detemir, biphasic insulin aspart, meal-time insulin aspart, alone or in combination, all ± OGLDs [10] and [11] x P. Home, N. El 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 S. Shah, A. Zilov, R. Malek, P. Soewondo, O. Bech, L. Litwak. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364-370 Abstract, Full-text, PDF, Crossref. .

The primary overall objective of the study was to determine the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to the study insulin between baseline and final visit. Secondary safety and effectiveness assessments included change in number of overall and nocturnal hypoglycaemic events in the last 4 weeks before interim and final visits, compared with the last 4 weeks before baseline visit. Confirmed major, minor and nocturnal hypoglycaemic events were as defined previously [10] x P. Home, N. El 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. . Efficacy assessments were change in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), body weight, systolic blood pressure (SBP) and lipid profile between baseline and final visit. Health-related quality of life (HRQoL) was measured using the EQ-5D Questionnaire [12] 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 study end [11] x S. Shah, A. Zilov, R. Malek, P. Soewondo, O. Bech, L. Litwak. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364-370 Abstract, Full-text, PDF, Crossref. .

The sub-groups investigated for this analysis were: 1) participants who were previously treated with a basal insulin and then added meal-time insulin aspart; 2) participants who were previously treated with a premix insulin and who switched to a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin; 3) participants who were previously treated with NPH insulin plus human unmodified insulin as a meal-time insulin and who switched to basal insulin plus insulin aspart; 4) participants who were insulin-naïve who started a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin. Data for those insulin-naïve participants who started insulin aspart alone have been previously published [11] x S. Shah, A. Zilov, R. Malek, P. Soewondo, O. Bech, L. Litwak. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364-370 Abstract, Full-text, PDF, Crossref. .

Continuous variables were summarised using descriptive statistics and discrete variables were summarised using frequency tables (n [%]). All statistical analyses were two-sided, using a pre-specified 5% significance level. Change from baseline HbA1c, FPG, PPPG and blood lipids was analysed using Student's paired t-test. The data analysis was generated by Novo Nordisk using SAS software, Version 9.1.3 (Cary, NC, USA).

References

Label Authors Title Source Year
[10]

References in context

  • The A1chieve study investigated insulin analogue use in people with type 2 diabetes across four continents in the non-Western world [10], and recruited 66,726 participants.
    Go to context

  • Confirmed major, minor and nocturnal hypoglycaemic events were as defined previously [10].
    Go to context

P. Home, N. El 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
[11]

References in context

  • The primary overall objective of the study was to determine the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to the study insulin between baseline and final visit.
    Go to context

  • The sub-groups investigated for this analysis were: 1) participants who were previously treated with a basal insulin and then added meal-time insulin aspart; 2) participants who were previously treated with a premix insulin and who switched to a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin; 3) participants who were previously treated with NPH insulin plus human unmodified insulin as a meal-time insulin and who switched to basal insulin plus insulin aspart; 4) participants who were insulin-naïve who started a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin.
    Go to context

S. Shah, A. Zilov, R. Malek, P. Soewondo, O. Bech, L. Litwak Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study Abstract, Full-text, PDF, Crossref. Diabetes Res Clin Pract. 2011;94:364-370 2011
[12]

References in context

  • The primary overall objective of the study was to determine the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to the study insulin between baseline and final visit.
    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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