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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 461-464

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


Department of Endocrinology, Gulf Diabetes Center, Manama, Bahrain

Date of Web Publication27-Nov-2013

Correspondence Address:
Wiam Ibrahim Hussein
Gulf Diabetes Centre, Manama
Bahrain
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122078

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   Abstract 

Background: The A 1 chieve, is a multicentric (28 countries), 24-weeks, non-interventional study to evaluate 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 Manama, kingdom of Bahrain. Results: A total of 115 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 = 67), insulin detemir (n = 16), insulin aspart (n = 4), basal insulin plus insulin aspart (n = 21) and other insulin combinations (n = 7). At baseline, glycaemic control was poor for both insulin naïve (mean HbA1c: 10.2%) and insulin users (mean HbA1c: 9.8%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: −1.1%, insulin users: −1.3%). 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.


How to cite this article:
Hussein WI, Taha N. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Bahraini cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:461-4

How to cite this URL:
Hussein WI, Taha N. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Bahraini cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Nov 22];17, Suppl S2:461-4. Available from: http://www.ijem.in/text.asp?2013/17/8/461/122078


   Introduction Top


The prevalence of diabetes in Bahrain is estimated to be 22.4%, affecting 185 thousand and is ranked the 9 th in the world. [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-weeks, 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 Manama, Kingdom of Bahrain.


   Materials and Methods Top


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


   Results Top


A total of 115 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 started on or were switched to biphasic insulin aspart (58.3%). Other groups were on insulin detemir (n = 16), insulin aspart (n = 4), basal insulin plus insulin aspart (n = 21) and other insulin combinations (n = 7).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events reduced from 4.3 events/patient-year to 1.3 events/patient-year in the insulin users group and increased from 0.0 events/patient-year to 1.9 events/patient-year in the 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. SADRs including major hypoglycaemic events did not occur in the study patients. Body weight increased while overall lipid profile improved at week 24 in the entire 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, 67 patients started on biphasic insulin aspart ± OGLD, of which 19 (28.3%) were insulin naïve patients and 48 (71.7%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 4.6 events/patient-year to 1.6 events/patient-year in the insulin user group and increased from 0.0 events/patient-year to 1.6 events/patient-year in the insulin naive group. Body weight increased after 24 weeks 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 users 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, 21 patients were started on basal + insulin aspart ± OGLD, of which 2 (9.5%) were insulin naïve patients and 19 (90.5%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 1.4 events/patient-year to 0.9 events/patient-year in the insulin users group, whereas insulin hypoglycaemic events remained nil similar to that of baseline in insulin naive group. Body weight increased for insulin users 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 parameters of glycaemic control improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs in the insulin users [Table 10].
Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

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Insulin detemir ± OGLD

Of the total cohort, 16 patients were started on insulin detemir ± OGLD, of which 14 (87.5%) were insulin naïve patients and 2 (12.5%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 13.0 events/patient-year to 0.0 events/patient-year in the insulin users group, whereas hypoglycaemia increased from 0.0 events/patient-year to 3.6 events/patient-year in insulin naive group. A small decrease in body weight was observed in the insulin naive group [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 in the insulin naive group, whereas mean HbA 1 c values deteriorated in the insulin users [Table 13].
Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

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Insulin aspart ± OGLD

Of the total cohort, 4 patients started on insulin aspart ± OGLD, of which 2 (50%) were insulin naïve patients and 2 (50%) were insulin users. After 24 weeks of starting treatment or switching to insulin aspart, hypoglycaemia remained nil, similar to that of baseline for both insulin naïve and insulin users groups. An increase in body weight was also observed in both the groups. Mean HbA1c and PPPG values improved in the insulin naïve group while mean PPPG values improved in insulin users.


   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. SADRs including major hypoglycaemic events did not occur in the study patients. Body weight increased in the overall cohort. Though the findings are limited by the number of patients, still the trend indicates that insulin analogues can be considered effective and possesses a safe profile for treating type 2 diabetes in Manama, Kingdom of Bahrain.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed. 2012. Update. Available from: http://www.idf.org/diabetesatlas/5e/update2012.  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 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
[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]



 

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