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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 422-425

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


Department of Diabetes, Endocrinology and Nutrition, Hassan II University Hospital, Fes, Morocco

Date of Web Publication27-Nov-2013

Correspondence Address:
Farida Ajdi
Hassan II University Hospital, Fes
Morocco
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122051

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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 Saiss, Morocco. Results: A total of 145 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 = 47), insulin detemir (n = 56), insulin aspart (n = 1), basal insulin plus insulin aspart (n = 35) and other insulin combinations (n = 6). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.4%) and insulin user (mean HbA1c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: −2.7%, insulin users: −2.5%). SADRs including major hypoglycaemia 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: A1 chieve study, insulin analogues, Saiss, type 2 diabetes mellitus


How to cite this article:
Ajdi F. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Saiss cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:422-5

How to cite this URL:
Ajdi F. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Saiss cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2020 Apr 5];17, Suppl S2:422-5. Available from: http://www.ijem.in/text.asp?2013/17/8/422/122051


   Introduction Top


Diabetes prevalence in Morocco is estimated to be 6.4%. [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 Saiss, Morocco.


   Materials and Methods Top


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


   Results Top


A total of 145 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 (38.6%) started on or were switched to insulin detemir. Other groups were biphasic insulin aspart (n = 47), insulin aspart (n = 1), basal insulin plus insulin aspart (n = 35) and other insulin combinations (n = 6).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 23.6 events/patient-year to 15.7 events/patient-year in insulin user group whereas hypoglycaemia increased from 2.3 events/patient-year to 3.1 events/patient-year in the insulin naïve 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 hypoglycaemia did not occur in any of the study patients. Blood pressure decreased and lipid profile improved in the total cohort, but the findings were limited by number of observations. Quality of life improved after 24 weeks [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, 47 patients started on biphasic insulin aspart ± OGLD, of which 33 (70.2%) were insulin naïve and 14 (29.8%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 30.6 events/patient-year to 22.3 events/patient-year in insulin users while hypoglycaemia increased from 0.0 events/patient-year to 0.8 events/patient-year in insulin naïve group. Quality of life improved at 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, 35 patients started on basal + insulin aspart ± OGLD, of which 10 (28.6%) were insulin naïve and 25 (71.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced for both insulin naïve and insulin user groups (insulin naïve: from 13.0 events/patient-year to 8.7 events/patient-year, insulin user: from 25.0 events/patient-year to 17.1 events/patient-year). 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 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, 56 patients started on insulin detemir ± OGLD, of which 44 (78.6%) were insulin naïve and 12 (21.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 14.1 events/patient-year to 6.5 events/patient-year in insulin users while hypoglycaemia increased from 1.8 events/patient-year to 4.0 events/patient-year in insulin naïve 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

Of the total cohort, only 1 patient started on or switched to insulin aspart ± OGLD and was insulin user.


   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 hypoglycaemia did not occur in any of the study patients. 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 Saiss, Morocco.

 
   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]



 

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