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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 458-460

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


Department of Internal Medicine, Al Thwarh and Private Clinic, Sanaa, Yemen

Date of Web Publication27-Nov-2013

Correspondence Address:
Zayed Atef
Al Thwarh and Private Clinic, Sanaa
Yemen
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122076

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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 Yemen. Results: A total of 104 patients were enrolled in the study. Three different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 94), insulin aspart (n = 4), basal insulin plus insulin aspart (n = 1) and other insulin combinations (n = 2). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.6%) 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: −1.8%). SADR's including major hypoglycaemia events 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, type 2 diabetes mellitus, Yemen


How to cite this article:
Atef Z, Al-Khawlany A, Gunaid AA. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yemen cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:458-60

How to cite this URL:
Atef Z, Al-Khawlany A, Gunaid AA. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yemen cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2020 Sep 25];17, Suppl S2:458-60. Available from: http://www.ijem.in/text.asp?2013/17/8/458/122076


   Introduction Top


Diabetes prevalence in Yemen is estimated to be 6.7%, affecting 727 thousand people. [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 Yemen.


   Materials and Methods Top


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


   Results Top


A total of 104 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 (90.4%) started on or were switched to biphasic insulin aspart. Other groups were insulin aspart (n = 4), basal insulin plus insulin aspart (n = 1) and other insulin combinations (n = 2).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemia increased for both insulin user (from 3.9 events/patient-year to 9.6 events/patient-year) and insulin naïve (from 0.2 events/patient-year to 2.1 events/patient-year) groups. However, hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. SADR's including major hypoglycaemia events did not occur in the study patients. Blood pressure decreased from baseline, while overall lipid profile improved at week 24 in complete cohort, however 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, 94 patients started on biphasic insulin aspart ± OGLD, of which 48 (51.1%) were insulin naïve and 46 (48.9%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes increased for both insulin naïve (from 0.3 events/patient-year to 2.1 events/patient-year) and insulin user (from 4.2 events/patient-year to 10.0 events/patient-year) groups. Body weight increased for both insulin naïve and user groups [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, one patient started on or was switched to basal + insulin aspart ± OGLD and was an insulin user. No efficacy data was available for this patient.

Insulin aspart ± OGLD

Of the total cohort, 4 patients started on insulin aspart ± OGLD, 3 (75%) were insulin naïve and 1 (25%) was insulin user. Hypoglycaemia was nil in both the groups similar to that of baseline. No efficacy data was available for this group.


   Conclusion Top


Our study reports improved glycaemic control following 24 weeks of treatment with biphasic insulin aspart (with or without OGLD). This regimen showed a decrease in FPG and PPPG, however improvement was higher in insulin naïve compared to insulin users. SADR's including major hypoglycaemia did not occur in 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 Yemen.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed. 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
[PUBMED]    
3.Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.  Back to cited text no. 3
[PUBMED]    
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]



 

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