Home | About us | Editorial board | Search | Ahead of print | Current issue | Archives | Submit article | Instructions | Subscribe | Contacts | Advertise | Login 
 
Search Article 
  
Advanced search 
  Users Online: 1256 Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  

 
Table of Contents
ORIGINAL ARTICLE
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 552-556

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


1 Belgaum Diabetes Centre, Belgaum, Karnataka, India
2 St. John's Medical College, Bangalore, Karnataka, India
3 Novo Nordisk India Pvt. Ltd., Bangalore, Karnataka, India
4 Apollo BGS Hospitals, Mysore, Karnataka, 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
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122132

Rights and Permissions
   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 Karnataka, India. Results: A total of 2243 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 = 1855), insulin detemir (n = 211), insulin aspart (n = 111), basal insulin plus insulin aspart (n = 16) and other insulin combinations (n = 40). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.2%) and insulin user (mean HbA 1 c: 9.0%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −1.4%, insulin users: −1.7%). 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, Karnataka, type 2 diabetes mellitus


How to cite this article:
Deshpande N, Ayyar V, Channabasavaiah R, Shetty R, Behl A. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Karnataka cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:552-6

How to cite this URL:
Deshpande N, Ayyar V, Channabasavaiah R, Shetty R, Behl A. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Karnataka cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2020 Mar 31];17, Suppl S2:552-6. Available from: http://www.ijem.in/text.asp?2013/17/8/552/122132


   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 Karnataka, India.


   Materials and Methods Top


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


   Results Top


A total of 2243 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin users is shown in [Table 1]. Glycaemic control at baseline was poor in this population. The majority of patients (82.7%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 211), insulin aspart (n = 111), basal insulin plus insulin aspart (n = 16) and other insulin combinations (n = 40).
Table 1: Overall demographic data

Click here to view


After 24 weeks of treatment, overall hypoglycaemic events reduced from 0.8 events/patient-year to 0.0 events/patient-year in insulin naïve group and from 6.4 events/patient-year to 0.1 events/patient-year in insulin users group. No hypoglycaemic episode in insulin naive group 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. Though blood pressure has shown a decreasing trend in the total cohort, but the finding was limited by number of observations. Quality of life improved at 24 weeks [Table 2] and [Table 3].
Table 2: Overall safety data

Click here to view
Table 3: Insulin dose

Click here to view


All parameters of glycaemic control improved from baseline to study end in the total cohort [Table 4].
Table 4: Overall efficacy data

Click here to view


Biphasic insulin aspart ± OGLD

Of the total cohort, 1855 patients started on biphasic insulin aspart ± OGLD, of which 1682 (90.7%) were insulin naïve and 173 (9.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced for both insulin naïve (from 0.8 events/patient-year to 0.0 events/patient-year) and insulin user (from 7.7 events/patient-year to 0.1 events/patient-year) groups. Body weight decreased and quality of life improved at 24 weeks [Table 5] and [Table 6].
Table 5: Biphasic insulin aspart±oral glucose-lowering drug safety data

Click here to view
Table 6: Insulin dose

Click here to view


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

Click here to view


Basal + insulin aspart ± OGLD

Of the total cohort, 16 patients started on basal + insulin aspart ± OGLD of which 10 (31.2%) were insulin naïve and 6 (68.8%) were insulin users. After 24 weeks of starting or switching to Basal + insulin aspart, hypoglycaemic events reduced from 4.7 events/patient-year to 0.0 events/patient-year in insulin naïve group, whereas hypoglycaemia was nil in insulin users 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

Click here to view
Table 9: Insulin dose

Click here to view


Mean HbA 1 c and PPPG values improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs for insulin naïve group. FPG values deteriorated for this group [Table 10].
Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

Click here to view


Insulin detemir ± OGLD

Of the total cohort, 211 patients started on insulin detemir ± OGLD, of which 203 (78.5%) were insulin naïve and 8 (21.5%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.8 events/patient-year to 0.0 events/patient-year in insulin naïve group, whereas hypoglycaemia was nil in insulin users similar to baseline. A decrease in body weight and improvement in quality of life was also observed at the end of the study [Table 11] and [Table 12].
Table 11: Insulin detemir±oral glucose-lowering drug safety data

Click here to view
Table 12: Insulin dose

Click here to view


All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for insulin-naïve group while mean HbA 1 c and FPG values improved in insulin users [Table 13].
Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

Click here to view


Insulin aspart ± OGLD

Of the total cohort, 111 patients started on insulin aspart ± OGLD, of which 106 (95.5%) were insulin naïve and 5 (4.5%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events decreased from 0.5 events/patient year to 0.0 in insulin naïve group and from 2.6 events/patient-year to 0.0 events/patient-year in insulin user group. Quality of life improved after 24 weeks of treatment [Table 14] and [Table 15].
Table 14: Insulin aspart±oral glucose-lowering drug safety data

Click here to view
Table 15: Insulin dose

Click here to view


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

Click here to view






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 reduced in insulin naïve group and a small increase in weight was noted 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 Karnataka, 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]



 

Top
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

 
  In this article
    Abstract
   Introduction
    Materials and Me...
   Results
   Conclusion
    References
    Article Tables

 Article Access Statistics
    Viewed559    
    Printed9    
    Emailed0    
    PDF Downloaded171    
    Comments [Add]    

Recommend this journal