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| ORIGINAL ARTICLE |
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| Year : 2013 | Volume
: 17
| Issue : 8 | Page : 569-573 |
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Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Tamil Nadu cohort of the A 1 chieve study
M Shunmugavelu1, J Giri2, Shahid Akhtar3, Raman Shetty3, AJ Asirvatham4
1 Trichy Diabetes Speciality Centre, Trichy, India
2 K.G Hospital and Post Graduate Medical Institute, Coimbatore, India
3 Novo Nordisk India Pvt. Ltd., Bangalore, India
4 Department of Diabetology, Madurai Medical College, Madurai, Tamil Nadu, India
| Date of Web Publication | 27-Nov-2013 |
Correspondence Address:
Raman Shetty
Novo Nordisk India Pvt. Ltd., Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2230-8210.122139
 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 Tamil Nadu, India. Results: A total of 2221 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 = 1707), insulin detemir (n = 270), insulin aspart (n = 85), basal insulin plus insulin aspart (n = 79) and other insulin combinations (n = 80). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.2%) 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: −1.7%, insulin users: −1.7%). SADRs including major hypoglycaemic events 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, Tamil Nadu, type 2 diabetes mellitus
How to cite this article:
Shunmugavelu M, Giri J, Akhtar S, Shetty R, Asirvatham A J. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Tamil Nadu cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:569-73 |
How to cite this URL:
Shunmugavelu M, Giri J, Akhtar S, Shetty R, Asirvatham A J. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Tamil Nadu cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jan 19];17, Suppl S2:569-73. Available from: https://www.ijem.in/text.asp?2013/17/8/569/122139 |
| Introduction | |  |
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 Tamil Nadu, India.
| Materials and Methods | | |
Please refer to editorial titled: The A1chieve study: Mapping the Ibn Battuta trail.
| Results | | |
A total of 2221 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 (76.86%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 270), insulin aspart (n = 85), basal insulin plus insulin aspart (n = 79) and other insulin combinations (n = 80).
After 24 weeks of treatment, overall hypoglycaemia reduced from 1.1 events/patient-year to 0.6 events/patient-year in insulin naïve group and from 3.9 events/patient-year to 2.0 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. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased from baseline, while overall lipid profile and quality of life improved at week 24 in total cohort [Table 2] and [Table 3].
All parameters of glycaemic control improved from baseline to study end in the total cohort [Table 4].
Biphasic insulin aspart ± OGLD
Of the total cohort, 1707 patients started on biphasic insulin aspart ± OGLD, of which 1314 (77.0%) were insulin naïve and 393 (23.0%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 0.9 events/patient-year to 0.6 events/patient-year in insulin naïve group and from 3.4 events/patient-year to 1.8 events/patient-year in insulin users. Quality of life improved at the end of the study [Table 5] and [Table 6].
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 group [Table 7]. | Table 7: Biphasic insulin aspart±oral glucose-lowering
drug effi cacy data
Click here to view |
Basal + insulin aspart ± OGLD
Of the total cohort, 79 patients who started on basal + insulin aspart ± OGLD, of which 35 (44.3%) were insulin naïve and 44 (55.7%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events reduced from 2.2 events/patient-year to 0.8 events/patient-year in insulin naïve group and from 6.5 events/patient-year to 1.7 events/patient-year in insulin users. Quality of life improved after 24 weeks of treatment [Table 8] and [Table 9].
All parameters of glycaemic control improved from baseline to study end in those who started on or switched to basal + insulin aspart ± OGLDs for both insulin naïve and insulin user groups [Table 10].
Insulin detemir ± OGLD
On the total cohort, 270 patients who started on insulin detemir ± OGLD, of which 224 (83.0%) were insulin naïve and 46 (17.0%) were insulin users. After 24 weeks of starting or switching to biphasic insulin detemir, hypoglycaemic events reduced from 2.2 events/patient-year to 0.7 events/patient-year in insulin naïve group and from 4.8 events/patient-year to 2.1 events/patient-year in insulin users group. A small increase in body weight was observed. Quality of life improved at 24 weeks [Table 11] and [Table 12].
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].
Insulin aspart ± OGLD
Of the total cohort, 85 patients who started on insulin aspart ± OGLD, of which 69 (81.2%) were insulin naïve and 16 (18.8%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart hypoglycaemic events reduced from 15.4 events/patient-year to 5.2 events/patient-year in insulin users group, while hypoglycaemia increased from 0.0 events/patient-year to 0.2 events/patient-year in insulin naïve group. An improvement in quality of life was observed after 24 weeks [Table 14] and [Table 15].
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].
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. A slight 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 Tamil Nadu, India.
| References | | |
| 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. 
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| 2. | Shetty P. Public health: India's diabetes time bomb. Nature 2012;485:S14-6.
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| 3. | Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.
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| 4. | Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.
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| 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.
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[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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