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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 584-587

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


1 KPC Medical College and Hospital, Kolkata, India
2 GD hospital and Diabetes Institute, Kolkata; Sun Valley Diabetes and Endocrine Centre, Guwahati, India
3 Fortis Hospital, Bangalore, India
4 Novo Nordisk India Pvt. Ltd., Bangalore, India
5 GD hospital and Diabetes Institute, Kolkata, India

Date of Web Publication27-Nov-2013

Correspondence Address:
Raman Shetty
Novo Nordisk India Pvt. Ltd., Plot No. 32, 47 - 50, EPIP Area, Whitefield, Bangalore
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122144

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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 Kolkata, India. Results: A total of 576 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 = 417), insulin detemir (n = 70), insulin aspart (n = 55), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 15). At baseline, glycaemic control was poor for both insulin naïve (mean HbA 1 c: 8.3%) and insulin user (mean HbA 1 c: 8.6%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −1.3%, insulin users: −1.4%). SADRs including major hypoglycaemic events or episodes did not occur 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, Kolkata, type 2 diabetes mellitus


How to cite this article:
Majumder A, Singh AK, Gangopadhyay KK, Sen R, Shetty R, Majumdar S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Kolkata cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:584-7

How to cite this URL:
Majumder A, Singh AK, Gangopadhyay KK, Sen R, Shetty R, Majumdar S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Kolkata cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2019 Sep 22];17, Suppl S2:584-7. Available from: http://www.ijem.in/text.asp?2013/17/8/584/122144


   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 are 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 hypoglycaemia 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 Kolkata, India.


   Materials and Methods Top


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


   Results Top


A total of 576 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 (72.4%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 70), insulin aspart (n = 55), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 15).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events increased in both insulin naïve (from 0.0 events/patient-year to 0.7 events/patient-year) and insulin user (from 0.0 events/patient-year to 1.2 events/patient-year) groups. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased from baseline, while overall lipid profile improved at week 24 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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Mean HbA 1 c and FPG values 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, 417 patients started on biphasic insulin aspart ± OGLD, of which 332 (79.6%) were insulin naïve and 85 (20.4%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events increased in both insulin naïve (from 0.0 events/patient-year to 0.8 events/patient-year) and insulin user (from 0.0 events/patient-year to 1.4 events/patient-year) 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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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 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, 19 patients started on basal + insulin aspart ± OGLD, of which 11 (57.9%) were insulin naïve and 8 (42.1%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemia was nil, similar to baseline 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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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 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, 70 patients started on insulin detemir ± OGLD was 70, of which 60 (85.7%) were insulin naïve and 10 (14.3%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events increased from 0.0 events/patient-year to 0.5 events/patient-year in insulin naïve group while hypoglycaemia was nil in insulin users group, similar to baseline [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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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 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, 55 patients started on insulin aspart ± OGLD was 55, of which 54 (98.1%) were insulin naïve and 1 (1.9%) was insulin user. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events increased from 0.0 events/patient-year to 0.3 events/patient-year in insulin naïve group whereas hypoglycaemia was nil in insulin user, similar to baseline [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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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 16].
Table 16: Insulin aspart±oral glucose-lowering drug efficacy data

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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. A small increase in body weight was observed for the total cohort. SADRs including major hypoglycaemic events did not occur in any of 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 Kolkata, 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 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. 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], [Table 16]



 

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