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 : 445-448

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


1 Department of Internal Medicine, Riyadh Care Hospital, Riyadh, Saudi Arabia
2 Department of Endocrinology, Suleiman El Habib-Rayan Branch, Riyadh, Saudi Arabia
3 Department of Endocrinology and Internal Medicine, Specialized Medical Centre, Riyadh, Saudi Arabia

Date of Web Publication27-Nov-2013

Correspondence Address:
Muhamed Shahed Omar
Riyadh Care Hospital, Riyadh
Saudi Arabia
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122067

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 Central Saudi Arabia. Results: A total of 2819 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 = 1100), insulin detemir (n = 1156), insulin aspart (n = 34), basal insulin plus insulin aspart (n = 314) and other insulin combinations (n = 170). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.9%) and insulin user (mean HbA 1 c: 9.8%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA 1 c (insulin naïve: −2.6%, insulin users: −2.5%). 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.

Keywords: A 1 chieve study, Central Saudi Arabia, insulin analogues, type 2 diabetes mellitus


How to cite this article:
Omar MS, Abdulwahid N, Ali SS. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Central Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:445-8

How to cite this URL:
Omar MS, Abdulwahid N, Ali SS. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Central Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jan 19];17, Suppl S2:445-8. Available from: https://www.ijem.in/text.asp?2013/17/8/445/122067


   Introduction Top


2.7 million people are estimated to have diabetes in Saudi Arabia, with estimated prevalence of 16.2%. [1] Fear of hypoglycaemia and gain in body weight act as 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-week, 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 Central Saudi Arabia.


   Materials and Methods Top


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


   Results Top


A total of 2819 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 switched to insulin detemir (41.0%). Other groups were biphasic insulin aspart (1100), Basal plus insulin aspart (n = 314), insulin aspart (n = 34) and other insulin combinations (n = 170).
Table 1: Overall demographic data

Click here to view


After 24 weeks of treatment, overall hypoglycaemic events reduced from 13.0 events/patient-year to 2.1 events/patient-year in insulin user group and from 1.4 events/patient-year to 0.7 events/patient-year in insulin naive group. The hypoglycaemia incidence in insulin naive group at 24 weeks was lower than that observed in insulin users at baseline. SADRs including major hypoglycaemic events did not occur in any of the study patients. A decrease in body weight was noted at the end of the study. Blood pressure decreased and lipid profile improved at week 24 in the complete cohort [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. More than one third of patients achieved HbA 1 c < 7.0% at week 24 [Table 4].
Table 4: Overall efficacy data

Click here to view


Biphasic insulin aspart ± OGLD

Of the total cohort, 1100 patients started on biphasic insulin aspart ± OGLD, of which 605 (55%) were insulin naïve and 495 (45%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 0.8 events/patient-year to 0.7 events/patient-year in insulin naïve group and from 5.5 events/patient-year to 1.0 events/patient-year in insulin users group. Body weight decreased in insulin naïve group at the end of the study [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 314 patients started on basal + insulin aspart ± OGLD, of which 103 (32.8%) were insulin naïve and 211 (67.2%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 4.0 events/patient-year to 2.3 events/patient-year in insulin naïve group and from 22.6 events/patient-year to 3.7 events/patient-year in insulin users group. Body weight decreased at the end of 24 weeks [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


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

Click here to view


Insulin detemir ± OGLD

Of the total cohort, 1156 patients who started on insulin detemir ± OGLD, of which 905 (78.2%) were insulin naïve and 251 (21.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 1.5 events/patient-year to 0.5 events/patient-year in insulin naïve group and from 14.9 events/patient-year to 2.0 events/patient-year in insulin users group. Body weight decreased at the end of 24 weeks [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 both insulin-naïve and insulin user groups [Table 13].
Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

Click here to view


Insulin aspart ± OGLD

Of the total cohort, 34 patients who started on insulin aspart ± OGLD, of which 28 (82.3%) were insulin naïve and 6 (17.7%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events reduced from 23.8 events/patient-year to 0.0 events/patient-year in insulin user group, while hypoglycaemic events remained nil similar to that of baseline in insulin naive group [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



   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 or episodes did not occur in any of the study patients. A small weight reduction was noted for all regimens except for insulin aspart 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 Central Saudi Arabia.

 
   References Top

1.IDF Diabetes Atlas. 5 th ed. Available from: http://www.idf.org/atlasmap/atlasmap [Last accessed on 2013 Jun 10].  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 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. 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], [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
    Viewed817    
    Printed9    
    Emailed0    
    PDF Downloaded191    
    Comments [Add]    

Recommend this journal