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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 426-430

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Northern Tunisia cohort of the A 1 chieve study


Department of National Institute of Nutrition of Tunis, Tunisia

Date of Web Publication27-Nov-2013

Correspondence Address:
Samira Blouza
National Institute of Nutrition of Tunis, Department A, Tunis
Tunisia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122057

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   Abstract 

Background: The A 1 chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Northern Tunisia. Results: A total of 443 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 137), insulin detemir (n = 243), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 39) and other insulin combinations (n = 13). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.2%) and insulin user (mean HbA 1 c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA 1 c (insulin naïve: −2.1%, insulin users: −0.9%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

Keywords: A 1 chieve study, insulin analogues, Northern Tunisia, type 2 diabetes mellitus


How to cite this article:
Blouza S, Jamoussi H. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Northern Tunisia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:426-30

How to cite this URL:
Blouza S, Jamoussi H. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Northern Tunisia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Sep 22];17, Suppl S2:426-30. Available from: http://www.ijem.in/text.asp?2013/17/8/426/122057


   Introduction Top


The incidence of diabetes in Tunisia is estimated to be 8.9%. [1] Fear of hypoglycaemia and gain in body weight act as barriers for initiation of insulin therapy. [2] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypoglycaemia and favourable weight change. [3] A 1 chieve, a multinational, 24-week, non-interventional study, assessed the safety and effectiveness of insulin analogues in people with T2DM (n = 66,726) in routine clinical care. [4] This short communication presents the results for patients enrolled from Northern Tunisia.


   Materials and Methods Top


Please refer to editorial titled: The A 1 chieve study: Mapping the Ibn Battuta trail..


   Results Top


A total of 443 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin users is shown in the [Table 1]. Glycaemic control at baseline was poor in this population. The majority of patients (54.9%) started on or were switched to insulin detemir. Other groups were insulin aspart (n = 11), basal insulin plus insulin aspart (n = 39), biphasic insulin aspart (n = 137), and other insulin combinations (n = 13).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemia reduced from 18.4 events/patient-year to 3.2 events/patient-year in insulin user group whereas hypoglycaemic events increased from 0.8 events/patient-year to 1.5 events/patient-year in insulin naive group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. SADRs including major hypoglycaemic events did not occur in any of the study patients [Table 2] and [Table 3].
Table 2: Overall safety data

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Table 3: Insulin dose

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All parameters of glycaemic control improved from baseline to study end in the total cohort. [Table 4].
Table 4: Overall efficacy data

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Biphasic insulin aspart ± OGLD

Of the total cohort, 137 patients starting on biphasic insulin aspart ± OGLD, of which 13 (9.5%) were insulin naïve and 124 (90.5%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 1.0 events/patient-year to 0.0 events/patient-year in insulin naïve group and from 13.7 events/patient-year to 1.1 events/patient-year in insulin users group. A decrease in body weight was observed in insulin user group [Table 5] and [Table 6].
Table 5: Biphasic insulin aspart±oral glucose-lowering drug safety data

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Table 6: Insulin dose

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Mean HbA 1 c and FPG values improved from baseline to study end in those who started on or were switched to biphasic insulin aspart for insulin naïve group whereas all parameters of glycaemic control improved in insulin user group [Table 7].
Table 7: Biphasic insulin aspart±oral glucose-lowering drug efficacy data

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Basal + insulin aspart ± OGLD

Of the total cohort, 39 patients started on basal + insulin aspart ± OGLD, of which 1 (2.6%) was insulin naïve and 38 (97.4%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 55.8 events/patient-year to 9.9 events/patient-year in insulin user group [Table 8] and [Table 9].
Table 8: Basal+insulin aspart±oral glucose-lowering drug safety data

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Table 9: Insulin dose

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All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs for insulin user group [Table 10].
Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

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Insulin detemir ± OGLD

Of the total cohort, 243 patients started on insulin detemir ± OGLD, of which 130 (53.5%) were insulin naïve and 113 (46.5%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events increased from 0.8 events/patient-year to 1.6 events/patient-year in insulin naive group whereas hypoglycaemic events reduced from 11.7 events/patient-year to 1.7 events/patient-year in insulin users. A decrease in body weight was observed in insulin user group. An improvement in quality of life was also observed at the end of the study [Table 11] and [Table 12].
Table 11: Insulin detemir±oral glucose-lowering drug safety data

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Table 12: Insulin dose

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All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for both insulin-naïve and insulin user groups [Table 13].
Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

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Insulin aspart ± OGLD

Of the total cohort, 11 patients were started on basal + insulin aspart ± OGLD group and all were insulin users. After 24 weeks of treatment starting or switching to insulin aspart hypoglycaemic events reduced from 8.3 events/patient-year to 0.0 events/patient in insulin user group [Table 14], [Table 15].
Table 14: Insulin aspart±oral glucose-lowering drug safety data

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Table 15: Insulin dose

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All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin user group [Table 16].
Table 16: Insulin aspart±oral glucose-lowering drug efficacy data

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   Conclusion Top


Our study reports improved glycaemic control (HbA 1 c, FPG, PPPG) following 24 weeks of treatment with any of the insulin analogues (basal + insulin aspart; insulin detemir; insulin aspart) with or without OGLD. In patients who started on or switched to biphasic insulin aspart, mean HbA1c and FPG values improved in insulin naïve group whereas all parameters of glycaemic control improved in insulin user group. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients after 24 week of treatment. Overall, body weight increased in insulin naïve population while a decrease in body weight was observed in insulin users. Quality of life improved in total cohort. Though the findings are limited by number of patients, still the trend indicates that insulin analogues can be considered effective and possess a safe profile for treating type 2 diabetes in Northern Tunisia.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed. 2011. Available from: http://www.idf.org/atlasmap/atlasmap [Last accessed on 2013 Jun 10].  Back to cited text no. 1
    
2.Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.  Back to cited text no. 2
    
3.Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.  Back to cited text no. 3
    
4.Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A 1 chieve study: A 60 000-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.  Back to cited text no. 4
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 15], [Table 16]



 

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