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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 413-417

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A 1 chieve study


1 Department of Endocrinology and Metabolic diseases, Avicenne University Hospital, Rabat-Sale-Zemmour-Zaer, Morocco
2 Department of Endocrinology and Diabetology, Military hospital of instruction Mohammed V, Rabat-Sale-Zemmour-Zaer, Morocco

Date of Web Publication27-Nov-2013

Correspondence Address:
Abdelmjid Chraibi
Endocrinology and Metabolic diseases Department, Avicenne University Hospital, Rabat-Sale-Zemmour-Zaer
Morocco
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122045

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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 Rabat-Sale-Zemmour-Zaer region, Morocco. Results: A total of 424 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 = 177), insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.1%) and insulin user (mean HbA 1 c: 9.4%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA 1 c (insulin naïve: −2.5%, insulin users: −1.8%). Major hypoglycaemia was observed in the insulin user group after 24 weeks (0.1 events/patient-year). SADRs were reported in 0.5% of insulin users. 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, Rabat-Sale-Zemmour-Zaer, type 2 diabetes mellitus


How to cite this article:
Chraibi A, Belmejdoub G. Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:413-7

How to cite this URL:
Chraibi A, Belmejdoub G. Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Oct 23];17, Suppl S2:413-7. Available from: http://www.ijem.in/text.asp?2013/17/8/413/122045


   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 Rabat-Sale-Zemmour-Zaer region, 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 424 patients were enrolled in the study. The patient characteristics for the entire cohort, divided as insulin-naïve and insulin users are shown in the [Table 1]. Glycaemic control at baseline was poor in this population. The majority of patients (41.7%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemia reduced from 13.4 events/patient-year to 2.7 events/patient-year in insulin user group while hypoglycaemic events increased from 0.7 events/patient-year to 0.9 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. Major hypoglycaemic events or episodes occurred in the insulin user group. SADRs were reported in 0.5% of insulin users. Blood pressure and quality of life improved after 24 weeks. Although lipid profile improved in the total cohort, but the finding was 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, 177 patients started on biphasic insulin aspart ± OGLD, of which 79 (44.6%) were insulin naïve and 98 (55.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 8.8 events/patient-year to 3.6 events/patient-year in insulin user group whereas hypoglycaemia increased from 1.3 events/patient-year to 2.2 events/patient-year in insulin naïve group. Quality of life improved at the end of the study [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, 45 patients started on basal + insulin aspart ± OGLD, of which 4 (8.9%) were insulin naïve and 41 (91.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 36.5 events/patient-year to 3.1 events/patient-year in insulin user group. Quality of life also 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 [Table 10].
Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

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Insulin detemir ± OGLD

Of the total cohort, 150 patients started on insulin detemir ± OGLD, of which 116 (77.3%) were insulin naïve and 34 (22.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 13.0 events/patient-year to 0.5 events/patient-year in insulin users and from 0.1 events/patient-year to 0.0 events/patient-year in insulin naïve 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 insulin-naïve group while mean HbA 1 c and FPG values improved for insulin users [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 started on insulin aspart ± OGLD of which 2 (18.2%) were insulin naïve and 9 (81.8%) were insulin users [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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Mean HbA 1 c and mean PPPG improved from baseline to study end in those who started on or were switched insulin aspart ± OGLDs [Table 16].
Table 16: Insulin aspart±oral glucose-lowering drug efficacy data

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   Conclusion Top


Our study reports improved glycaemic control and quality of life 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. Major hypoglycaemia was observed in the insulin user group after 24 weeks. SADRs were reported in 0.5% of insulin user group. A small weight gain was observed for the overall 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 Rabat-Sale-Zemmour-Zaer region, Morocco.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed. 2011. Available from: http://www.idf.org/atlasmap/atlasma [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], [Table 14], [Table 15], [Table 16]



 

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