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ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 516-520

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


1 Department of Diabetology, S. L. Raheja Hospital for Diabetes, Mumbai, India
2 Jaslok Hospital and Research Centre, Mumbai, India
3 Dr. Kovil's Diabetes Centre, Mumbai, India

Date of Web Publication27-Nov-2013

Correspondence Address:
P G Talwalkar
S. L. Raheja Hospital for Diabetes, Mumbai
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122107

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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 Mumbai, India. Results: A total of 2112 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 = 1561), insulin detemir (n = 313), insulin aspart (n = 144), basal insulin plus insulin aspart (n = 53) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 8.7%) 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: −1.4%, insulin users: −1.8%). 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, Mumbai, type 2 diabetes mellitus


How to cite this article:
Talwalkar P G, Gupta V, Kovil R. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Mumbai cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:516-20

How to cite this URL:
Talwalkar P G, Gupta V, Kovil R. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Mumbai cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2018 Nov 17];17, Suppl S2:516-20. Available from: http://www.ijem.in/text.asp?2013/17/8/516/122107


   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 Mumbai, 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 2112 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 (73.9%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 313), insulin aspart (n = 144), basal insulin plus insulin aspart (n = 53) and other insulin combinations (n = 41).
Table 1: Overall demographic data

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After 24 weeks of treatment, overall hypoglycaemic events reduced from 1.5 events/patient-year to zero events in insulin user group while hypoglycaemia remained nil in insulin naïve group similar to that of baseline. No hypoglycaemic episode in insulin naive group even at 24 weeks suggests low event rate than insulin users at baseline. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased whereas overall lipid profile and quality of life improved at week 24 in the 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, 1561 patients started on biphasic insulin aspart ± OGLD, of which 1471 (94.2%) were insulin naïve and 90 (5.8%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 1.2 events/patient-year to 0.0 events/patient-year in insulin user group, whereas hypoglycaemia was nil in insulin naive group similar to baseline. A slight increase in body weight was observed. Quality of life improved after 24 weeks of treatment [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, 53 patients started on basal + insulin aspart ± OGLD, of which 27 (50.9%) were insulin naïve and 26 (49.1%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 1.0 events/patient-year to 0.0 events/patient-year in insulin user group, while hypoglycaemia was nil in insulin naive group similar to baseline. Quality of life improved 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 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, 313 patients started on insulin detemir ± OGLD was 313, of which 302 (96.5%) were insulin naïve and 11 (3.5%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events was nil in both insulin naïve and user groups similar to baseline. Body weight decreased and quality of life improved at 24 weeks [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, 144 patients started on insulin aspart ± OGLD, of which 131 (91.0%) were insulin naïve and 13 (9.0%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events reduced from 2.0 events/patient-year to 0.0 events/patient-year in insulin user group, whereas hypoglycaemia remained nil in insulin naïve group similar to baseline. Quality of life improved at the end of the study [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 and quality of life 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 or episodes did not occur in any of the study patients. Overall, body weight increased in insulin naïve group while there was no change in body weight for insulin user group. 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 Mumbai, 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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