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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 526-529

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


1 Diabetes Thyroid and Hormone Centre, Kota, Rajasthan, India
2 Satyam Hospital and Research Centre, Jodhpur, Rajasthan, India
3 SDMH and Research Centre, Jaipur, Rajasthan, India
4 Department of Endocrinology, RNT Medical College, Udaipur, Rajasthan, India
5 Sanjeevani Hospital and Diabetes Centre, Jaipur, Rajasthan, India

Date of Web Publication27-Nov-2013

Correspondence Address:
Akhil Joshi
Diabetes Thyroid and Hormone Centre, Kota
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122116

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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 Rajasthan, India. Results: A total of 477 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 340), insulin detemir (n = 90), insulin aspart (n = 37), basal insulin plus insulin aspart (n = 7) and other insulin combinations (n = 2). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 8.3%) and insulin user (mean HbA 1 c: 8.4%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −0.9%, insulin users: −1.2%). Major hypoglycaemic events decreased from 0.5 events/patient-year to 0.0 events/patient-year in insulin naïve group while no change from baseline (1.3 events/patients-year) was observed for insulin users. SADRs were not reported 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, Rajasthan, type 2 diabetes mellitus


How to cite this article:
Joshi A, Meenawat A, Patni R, Sharma D C, Panicker S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rajasthan cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:526-9

How to cite this URL:
Joshi A, Meenawat A, Patni R, Sharma D C, Panicker S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rajasthan cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Sep 22];17, Suppl S2:526-9. Available from: http://www.ijem.in/text.asp?2013/17/8/526/122116


   Introduction Top


62.4 million Indians were reported to have type 2 diabetes mellitus (T2DM) putting India on the forefront of diabetic epidemic across globe. [1],[2] Fear of hypoglycaemia and gain in body weight act as barriers for initiation of insulin therapy. [3] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypos and favourable weight change. [4] 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. [5] This short communication presents the results for patients enrolled from Rajasthan, India.


   Materials and Methods Top


Please refer to editorial titled: The A1chieve study: Mapping the Ibn Battuta trail.


   Results Top


A total of 477 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 (71.28%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 28), insulin aspart (n = 24), basal insulin plus insulin aspart (n = 13) and other insulin combinations (n = 3).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events reduced from 2.1 events/patient-year to 0.0 events/patient-year in insulin naïve group and from 6.8 events/patient-year to 0.0 events/patient-year in insulin users group. The hypoglycaemia incidence in insulin naive group at 24 weeks was lower than that observed in insulin users at baseline. Major hypoglycaemic events decreased from 0.5 events/patient-year to 0.0 events/patient-year in insulin naïve group while no change from baseline (1.3 events/patients-year) was observed for insulin user group. SADRs were not reported in any of the study patients. Quality of life improved after 24 weeks [Table 2] and [Table 3].
Table 2: Overall safety data

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Table 3: Insulin dose

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Mean HbA 1 c and FPG values improved from baseline to study end in the insulin naïve group [Table 4].
Table 4: Overall efficacy data

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Biphasic insulin aspart ± OGLD

Of the total cohort, 340 patients started on biphasic insulin aspart ± OGLD, of which 153 (45%) were insulin naïve and 187 (55%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 2.3 events/patient-year to 0.0 events/patient-year in insulin naïve group and from 6.3 events/patient-year to 0.0 events/patient-year in insulin users. Body weight decreased in the insulin naïve group. Quality of life improved 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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Mean HbA 1 c and FPG values improved from baseline to study end in those who started on or were switched to biphasic insulin aspart for insulin naïve group [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, 7 patients started on basal + insulin aspart ± OGLD, of which 2 (28.6%) were insulin naïve and 5 (71.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 10.4 events/patient-year to 0.0 events/patient-year in insulin users whereas hypoglycaemia remained nil in insulin naive group, similar to baseline. Quality of life improved after 24 weeks of treatment [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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Mean HbA 1 c and FPG values improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs for insulin naïve group.

Insulin detemir ± OGLD

Of the total cohort, 90 patients started on insulin detemir ± OGLD, of which 57 (63.3%) were insulin naïve and 33 (36.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 2.5 events/patient-year to 0.0 events/patient-year in insulin naïve and from 6.3 events/patient-year to 0.0 events/patient-year in insulin user groups [Table 10] and [Table 11].
Table 10: Insulin detemir±oral glucose-lowering drug safety data

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Table 11: Insulin dose

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Mean HbA 1 c and FPG values improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for insulin-naïve group [Table 12].
Table 12: 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 26 (70.3%) were insulin naïve and 11 (29.7%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 14.2 events/patient-year to 0.0 events/patient-year in insulin users whereas, hypoglycaemic events remained nil in insulin users, similar to baseline. Quality of life improved at the end of the study [Table 13] and [Table 14].
Table 13: Insulin aspart±oral glucose-lowering drug safety data

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Table 14: Insulin dose

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Mean HbA 1 c and FPG values improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin naïve group [Table 15].
Table 15: Insulin aspart±oral glucose-lowering drug efficacy data

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   Conclusion Top


Our study reports improved glycaemic control (HbA 1 c, FPG) 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. Quality of life improved in the total cohort. Major hypoglycaemic events decreased from 0.5 events/patient-year to 0.0 events/patient-year in insulin naïve group while no change from baseline (1.3 events/patients-year) was observed for insulin user group. SADRs were not reported in any of the study patients. Overall, body weight reduced in insulin naïve group whereas no change in body weight was observed for insulin users. 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 Rajasthan, India.

 
   References Top

1.Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047-53.  Back to cited text no. 1
    
2.Shetty P. Public health: India's diabetes time bomb. Nature 2012;485:S14-6.  Back to cited text no. 2
    
3.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. 3
    
4.Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.  Back to cited text no. 4
    
5.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. 5
    



 
 
    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]



 

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