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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 482-485

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


Department of Endocrinology, Omani Medical Centre, Muscat, Oman

Date of Web Publication27-Nov-2013

Correspondence Address:
Mustafa Al Abousi
Omani Medical Centre, Muscat
Oman
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122090

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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 Oman. Results: A total of 349 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 = 121), insulin detemir (n = 171), insulin aspart (n = 2), basal insulin plus insulin aspart (n = 38) and other insulin combinations (n = 17). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.2%) and insulin user (mean HbA 1 c: 8.8%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −2.1%, insulin users: −1.6%). SADRs including major hypoglycaemic events did not occur in the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia and no weight gain.

Keywords: A 1 chieve study, insulin analogues, Oman, type 2 diabetes mellitus


How to cite this article:
Al Abousi M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Oman cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:482-5

How to cite this URL:
Al Abousi M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Oman cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jan 24];17, Suppl S2:482-5. Available from: https://www.ijem.in/text.asp?2013/17/8/482/122090


   Introduction Top


With 138 thousand people with diabetes, diabetes prevalence in Oman is estimated to be 7.6%. [1] Fear of hypoglycaemia and gain in body weight act as 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 Oman.


   Materials and Methods Top


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


   Results Top


A total of 349 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 (48.99%) started on or switched to insulin detemir. Other groups were insulin aspart (n = 2), basal insulin plus insulin aspart (n = 38), Biphasic insulin aspart (n = 121) and other insulin combinations (n = 17).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events reduced from 1.1 events/patient-year to 0.9 events/patient-year in insulin naive group and from 12.0 events/patient-year to 3.2 events/patient-year in insulin user 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 the study patients. Body weight decreased and overall lipid profile improved at week 24 in complete cohort [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. Approximately, more than half of the patients achieved HbA 1 c < 7.0% at week 24 [Table 4].
Table 4: Overall efficacy data

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Biphasic insulin aspart ± OGLD

Of the total cohort, 121 patients started on biphasic insulin aspart ± OGLD, of which 88 (72.7%) were insulin naïve and 33 (27.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 13.4 events/patient-year to 3.9 events/patient-year in insulin user group and increased from 1.4 events/patient-year to 0.9 events/patient-year in insulin naive group. A decrease in body weight was also observed 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, 38 patients started on basal + insulin aspart ± OGLD, of which 8 (21.1%) were insulin naïve and 30 (78.9%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 13.4 events/patient-year to 5.2 events/patient-year in insulin user group and increased from 0.0 events/patient-year to 1.6 events/patient-year in insulin naive group. Body weight decreased at the end of the study [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 aspects of glycaemic control improved from baseline to study end in those who started on or 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, 171 patients started on insulin detemir ± OGLD, of which 131 (76.6%) were insulin naïve and 40 (23.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 1.3 events/patient-year to 0.5 events/patient-year in insulin naive group and from 11.1 events/patient-year to 2.0 events/patient-year in insulin user group. A small decrease in body weight also observed at 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 aspects of glycaemic control improved from baseline to study end in those who started on or 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, 2 patients started on insulin aspart ± OGLD and both were insulin users. Similar to baseline, hypoglycaemia remained nil at 24 weeks in insulin user group. A decrease in body weight was also observed in insulin user group. All aspects of glycaemic control improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin user group.


   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. Their administration even caused a small weight reduction. Patient compliance was good with insulin analogues due to less painful injection and decreased fear of hypoglycaemia. SADRs including major hypoglycaemic events 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 Oman.

 
   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
    
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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