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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 399-403

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


1 Hospital Moulay El Hassan Belmehdi, Laayoune, Morocco
2 Hospital Hassan II, Agadir, Morocco
3 Prefetoral Hospital of Inezegane, Inzegane, Morocco

Date of Web Publication27-Nov-2013

Correspondence Address:
Hicham Boussouf
Hospital Moulay El Hassan Belmehdi, Laayoune
Morocco
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122040

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   Abstract 

Background: 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 Agadir, Morocco. Results: A total of 201 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 = 98), insulin detemir (n = 54), insulin aspart (n = 8), basal insulin plus insulin aspart (n = 8) and other insulin combinations (n = 33). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.7%) and insulin user (mean HbA 1 c: 9.1%) groups. After 24 weeks of treatment, both groups showed improvement in HbA 1 c (insulin naïve: −2.7%, insulin users: −1.3%). No major hypoglycaemia was observed at 24 weeks. SADRs were reported in 1.5% 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, Agadir, insulin analogues, type 2 diabetes mellitus


How to cite this article:
Boussouf H, Mouniri M, Oudrhiri M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Agadir cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:399-403

How to cite this URL:
Boussouf H, Mouniri M, Oudrhiri M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Agadir cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Nov 13];17, Suppl S2:399-403. Available from: http://www.ijem.in/text.asp?2013/17/8/399/122040


   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 Agadir, 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 201 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 (48.8%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 54), insulin aspart (n = 8), basal insulin plus insulin aspart (n = 8) and other insulin combinations (n = 33).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemia reduced from 20.8 events/patient-year to 4.3 events/patient-year in insulin user group whereas hypoglycaemic events increased from 0.3 events/patient-year to 2.0 events/patient-year in 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 did not occur in any of the study patients. SADRs were reported in 1.5% of insulin users. Blood pressure and lipid profile improved in the total cohort, but the findings were limited by number of observations. Quality of life also improved after 24 weeks of treatment [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, 98 patients started on biphasic insulin aspart ± OGLD, of which 69 (70.4%) were insulin naïve and 29 (29.6%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 21.5 events/patient-year to 1.2 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.4 events/patient-year to 2.4 events/patient-year in insulin naïve group. Quality of life also 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, 8 patients started on basal + insulin aspart ± OGLD, of which 1 (12.5%) was insulin naïve and 7 (87.5%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 26.0 events/patient-year to 9.3 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 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, 54 patients started on insulin detemir ± OGLD, of which 46 (85.2%) were insulin naïve and 8 (14.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 11.4 events/patient-year to 0.0 events/patient-year in insulin user group whereas hypoglycaemic events increased from 0.0 to 1.1 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 whereas mean HbA 1 c and FPG values improved for insulin user group [Table 13].
Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

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Insulin aspart ± OGLD

Of the total cohort, 8 patients started on insulin aspart ± OGLD, of which 5 (62.5%) were insulin naïve and 3 (37.5%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 65.0 events/patient-year to 6.5 events/patient-year in insulin user group [Table 14]. Quality of life improved in both the groups.[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 FPG values improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin-naïve 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 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. Major hypoglycaemic episodes were null at 24 weeks. SADRs were reported in 1.5% of insulin users. Overall, body weight increased in insulin naïve population and decreased in insulin users. 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 in Agadir, 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 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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