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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 437-440

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


1 Department of Internal Medicine, Al Rafie Hospital, Mekkah, Saudi Arabia
2 Department of Internal Medicine, Alhada Armed Forces Hospital, Taif, Saudi Arabia
3 Department of Internal Medicine, Bashrahil Hospital, Mekkah, Saudi Arabia

Date of Web Publication27-Nov-2013

Correspondence Address:
Helmy El Gendy
Al Rafie Hospital, Mekkah
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122063

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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 participants enrolled from Taif, Saudi Arabia. Results: A total of 791 subjects were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients were started on or were switched to biphasic insulin aspart (n = 238), insulin detemir (n = 325), insulin aspart (n = 9), basal insulin plus insulin aspart (n = 85) and other insulin combinations (n = 127). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.7%) and insulin user (mean HbA 1 c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA 1 c (insulin naïve: −2.3%, insulin users: −2.6%). 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.

Keywords: A 1 chieve study, insulin analogues, type 2 diabetes mellitus, Taif, Saudi Arabia


How to cite this article:
El Gendy H, Al Sifri S, Ghazy M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Taif, Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:437-40

How to cite this URL:
El Gendy H, Al Sifri S, Ghazy M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Taif, Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jan 20];17, Suppl S2:437-40. Available from: https://www.ijem.in/text.asp?2013/17/8/437/122063


   Introduction Top


2.7 million people are estimated to have diabetes in Saudi Arabia, with estimated prevalence of 16.2%. [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 participants enrolled from Taif, 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 791 subjects were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin user is shown in the [Table 1]. Glycaemic control at baseline was poor in this population. The majority of patients (41.1%) were started on or were switched to insulin detemir. Other groups were biphasic insulin aspart (n = 238), insulin aspart (n = 9), basal insulin plus insulin aspart (n = 85) and other insulin combinations (n = 127).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemia reduced for both insulin naïve (from 0.6 to 0.3 events/patient-year) and insulin user (2.3 to 0.5 events/patient-year) groups. 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 any of the study patients. A decrease in body weight was observed after 24 weeks. Blood pressure and lipid profile improved in the total 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, 238 patients started on biphasic insulin aspart ± OGLD, of which 131 (55%) were insulin naïve and 107 (45%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events or episodes reduced for both insulin naïve and user groups (insulin naïve: from 1.0 to 0.5 events/patient-year, insulin users: from 1.1 to 0.5 events/patient-year) [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, 85 patients started on basal + insulin aspart ± OGLD, 28 (32.9%) were insulin naïve and 57 (67.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 7.5 to 0.2 events/patient-year in insulin user group. Hypoglycaemia was nil in insulin naïve group similar to that of baseline. A decrease in body weight was also observed in both the groups. [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 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, 325 patients started on insulin detemir ± OGLD, of which 202 (62.1%) were insulin naïve and 123 (37.9%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.7 to 0.0 events/patient-year in insulin users while hypoglycaemia increased from 0.1 to 0.3 events/patient-year in insulin naïve group [Table 11] and [Table 12]. Body weight decreased in both the groups.
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, 9 patients started on insulin aspart ± OGLD of which 5 (55.5%) were insulin naïve and 4 (44.5%) were insulin users. After 24 weeks of treatment, hypoglycaemic events decreased from 13.0 to 0.0 events/patient-year in insulin naïve group. Hypoglycaemia was nil in insulin user group similar to that of baseline. A decrease in body weight was noted for both insulin naïve and user groups [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 insulin aspart ± OGLDs for both insulin naïve insulin user 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. Their administration even caused a small weight reduction. 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 in Taif, 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
    
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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