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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 453-457

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


1 Department of Internal Medicine, Endocrinology, Mana General Hospital, Jubail, Saudi Arabia
2 Department of Internal Medicine, Endocrinology, Mana General Hospital, Khobar, Saudi Arabia
3 Department of Endocrinology, Saad Specialist Hospital, Khobar, Saudi Arabia

Date of Web Publication27-Nov-2013

Correspondence Address:
Faisal Hashim
Mana General Hospital, Jubail
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122074

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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 Eastern Saudi Arabia. Results: A total of 1040 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 = 489), insulin detemir (n = 360), insulin aspart (n = 37), basal insulin plus insulin aspart (n = 96) and other insulin combinations (n = 57). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.0%) and insulin user (mean HbA 1 c: 9.2%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −2.7%, insulin users: −1.7%). No major hypoglycaemic episodes were observed at 24 weeks. SADR was reported in 0.6% 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, Eastern Saudi Arabia, insulin analogues, type 2 diabetes mellitus


How to cite this article:
Hashim F, Yasser MA, Khatib O. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Eastern Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:453-7

How to cite this URL:
Hashim F, Yasser MA, Khatib O. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Eastern Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Sep 26];17, Suppl S2:453-7. Available from: https://www.ijem.in/text.asp?2013/17/8/453/122074


   Introduction Top


2.7 million people are estimated to have diabetes in Saudi Arabia, with estimated prevalence of 16.2%. [1] 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 Eastern Saudi Arabia.


   Materials and Methods Top


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


   Results Top


A total of 1040 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 (47.02%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 360), insulin aspart (n = 37), basal insulin plus insulin aspart (n = 96) and other insulin combinations (n = 57).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events reduced from 10.1 events/patient-year to 3.9 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.7 events/patient-year to 3.9 events/patient-year in insulin naive group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. No major hypoglycaemic episodes were observed at 24 weeks. SADR was reported in 0.6% of insulin users. A slight decrease in body weight was noted. Blood pressure 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 [Table 4].
Table 4: Overall efficacy data

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Biphasic insulin aspart ± OGLD

Of the total cohort, 489 patients started on biphasic insulin aspart ± OGLD, of which 238 (48.6%) were insulin naïve and 251 (51.4%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 8.2 events/patient-year to 5.7 events/patient-year in insulin user group while hypoglycaemia increased from 8.2 events/patient-year to 5.7 events/patient-year in insulin naive group. Body weight decreased in both insulin naïve and insulin 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, 96 patients started on basal + insulin aspart ± OGLD, of which 16 (16.7%) were insulin naïve and 80 (83.3%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart hypoglycaemic events reduced from 13.7 events/patient-year to 2.3 events/patient-year in insulin user group, whereas hypoglycaemia increased from 0.0 events/patient-year to 8.1 events/patient-year in insulin naive group. A decrease in body weight was observed in insulin naive 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 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, 360 of patients started on insulin detemir ± OGLD, of which 282 (78.3%) were insulin naïve and 78 (21.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 6.2 events/patient-year to 2.9 events/patient-year in insulin user group, while hypoglycaemia increased from 0.5 events/patient-year to 3.3 events/patient-year in insulin naive group. A decrease in body weight was observed in both insulin naive and insulin user groups [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, 37 patients started on insulin aspart ± OGLD, of which 17 (45.9%) were insulin naïve and 20 (54.1%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart, hypoglycaemic events reduced from 10.4 events/patient-year to 0.0 events/patient-year in insulin user group, whereas hypoglycaemia increased from 3.1 events/patient-year to 8.4 events/patient-year in insulin naive group. A decrease in body weight was observed in insulin user group [Table 14] and [Table 15].
Table 14: Insulin aspart±oral glucose-lowering drug safety data

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Table 15: 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 aspart ± OGLDs for both insulin naïve and insulin user groups [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. No major hypoglycaemic episodes were observed at 24 weeks. SADR was reported in 0.6% of insulin users. A small weight reduction was observed at week 24 in the complete 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 Eastern Saudi Arabia.

 
   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
[PUBMED]    



 
 
    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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