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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 431-434

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


1 Department of Endocrinology, Hedi Chaker Hospital, Sfax, Tunisia
2 Department of Endocrinology and Internal Medicine, Fattouma Bourguiba Hospital, Monastir, Tunisia

Date of Web Publication27-Nov-2013

Correspondence Address:
Mohamed Abid
Hedi Chaker Hospital, Sfax
Tunisia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122059

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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 Central and Southern Tunisia. Results: A total of 142 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 = 32), insulin detemir (n = 66), insulin aspart (n = 2), basal insulin plus insulin aspart (n = 39) and other insulin combinations (n = 3). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.5%) and insulin user (mean HbA 1 c: 9.9%) groups. After 24 weeks of treatment, both groups showed improvement in HbA 1 c (insulin naïve: −2.4%, insulin users: −1.7%). 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, Central and Southern Tunisia, type 2 diabetes mellitus


How to cite this article:
Abid M, Khochtali I. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Central and Southern Tunisia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:431-4

How to cite this URL:
Abid M, Khochtali I. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Central and Southern Tunisia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Nov 22];17, Suppl S2:431-4. Available from: http://www.ijem.in/text.asp?2013/17/8/431/122059


   Introduction Top


The incidence of diabetes in Tunisia is estimated to be 8.9%. [1] Fear of hypoglycaemia and gain in body weight are 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 Central and Southern 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 142 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 (46.5%) started on or were switched to insulin detemir. Other groups were Biphasic insulin aspart (n = 32), basal + insulin aspart (n = 39), insulin aspart (n = 2) and other insulin combinations (n = 3).
Table 1: Overall demographic data

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After 24 weeks of treatment, hypoglycaemic events reduced from 16.7 events/patient-year to 4.9 events/patient-year in insulin user group whereas no change in overall hypoglycaemia was noted for insulin naïve group. The hypoglycaemia incidence in insulin naive group at 24 weeks was lower than that observed in insulin users at baseline. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased whereas overall lipid profile and quality of life improved at week 24 in the cohort but the findings were limited by number of observations [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, 32 patients started on biphasic insulin aspart ± OGLD, of which 9 (28.1%) were insulin naïve and 23 (71.9%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 15.3 events/patient-year to 7.9 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.0 events/patient-year to 7.8 events/patient-year in insulin naive group. Quality of life improved after 24 weeks [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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All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to biphasic insulin aspart for both insulin naïve and insulin user groups [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 9 (23.1%) were insulin naïve and 30 (76.9%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 7.8 events/patient-year to 2.7 events/patient-year in insulin user group while hypoglycaemia increased from 0.0 events/patient-year to 1.4 events/patient-year in insulin naive group. Quality of life improved after 24 weeks [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 both insulin naïve and insulin user groups [Table 10].
Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

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Insulin detemir ± OGLD

Of the total cohort, 66 patients started insulin detemir ± OGLD, of which 42 (63.6%) were insulin naïve and 24 (36.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 2.2 events/patient-year to 0.7 events/patient-year in insulin naïve group and from 30.3 events/patient-year to 3.9 events/patient-year in insulin user group. A decrease in body weight was also observed for insulin user group. Quality of life improved after 24 weeks [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

Only two patients started on insulin aspart ± OGLD group and both were insulin users. After 24 weeks of treatment starting or switching to insulin aspart, hypoglycaemic events increased from 0.0 events/patient-year to 19.5 events/patient-year. All parameters of glycaemic control improved from baseline to study end in these patients.


   Conclusion Top


Our study reports improved glycaemic control following 24 weeks of treatment with any of the insulin analogues (biphasic insulin aspart; basal + insulin aspart; insulin detemir; Insulin aspart) with or without OGLD. Quality of life improved in the total cohort. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients after 24 week of treatment. Overall, a small weight reduction was noted in insulin user group. 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 Central and Southern Tunisia.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed.. 2011. Available from: http://www.idf.org/atlasmap/atlasmap [Last accessed on 2013 June 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 A1chieve 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]



 

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