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| ORIGINAL ARTICLE |
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| Year : 2013 | Volume
: 17
| Issue : 8 | Page : 530-533 |
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Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Delhi cohort of the A 1 chieve study
Sudhir Tripathi1, Neeru Gera2, Anil Motta3, Rajiva Gupta4
1 Sri Ganga Ram Hospital, New Delhi, India
2 Max Hospitals, New Delhi, India
3 Max Super Speciality Hospital, New Delhi, India
4 Upchaar Speciality Centre, New Delhi, India
| Date of Web Publication | 27-Nov-2013 |
Correspondence Address:
Sudhir Tripathi
Sri Ganga Ram Hospital New Delhi
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2230-8210.122118
 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 Delhi, India. Results: A total of 2242 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 = 1515), insulin detemir (n = 521), insulin aspart (n = 176), basal insulin plus insulin aspart (n = 11) and other insulin combinations (n = 19). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 10.0%) and insulin user (mean HbA 1 c: 11.0%) groups. After 24 weeks of treatment both the groups showed improvement in HbA 1 c (insulin naïve: −3.1%, insulin users: −3.6%). 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, Delhi, insulin analogues, type 2 diabetes mellitus
How to cite this article:
Tripathi S, Gera N, Motta A, Gupta R. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Delhi cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:530-3 |
How to cite this URL:
Tripathi S, Gera N, Motta A, Gupta R. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Delhi cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jan 19];17, Suppl S2:530-3. Available from: https://www.ijem.in/text.asp?2013/17/8/530/122118 |
| 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 Delhi, India.
| Materials and Methods | | |
Please refer to editorial titled: The A 1 chieve study: Mapping the Ibn Battuta trail.
| Results | | |
A total of 2242 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 (67.6%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 521), insulin aspart (n = 176), basal insulin plus insulin aspart (n = 11) and other insulin combinations (n = 19).
After 24 weeks of treatment, overall hypoglycaemic events reduced from 1.5 events/patient-year to 0.0 events/patient-year in the insulin naïve group and from 2.0 events/patient-year to 0.3 events/patient-year in the 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 or episodes did not occur in any of the study patients [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, 1515 patients started on biphasic insulin aspart ± OGLD, of which 1407 (92.9%) were insulin naïve and 108 (7.1%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events decreased from 1.3 events/patient-year to 0.0 events/patient-year in the insulin naïve group and from 2.3 events/patient-year to 0.3 events/patient-year in the insulin users group. Quality of life also improved by 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 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, 11 patients started on basal + insulin aspart ± OGLD, of which 08 (72.7%) were insulin naïve and 03 (27.3%) were insulin users. Body weight decreased and quality of life improved after 24 weeks of treatment in insulin naïve group [Table 8] and [Table 9].
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 insulin-naïve group [Table 10].
Insulin detemir ± OGLD
Of the total cohort, 521 patients started on insulin detemir ± OGLD, of which 472 (90.6%) were insulin naïve and 49 (9.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced in both insulin naïve (from 1.8 events/patient-year to 0.0 events/patient-year) and insulin user (from 1.6 events/patient-year to 0.3 events/patient-year) groups. Quality of life also improved at the end of the study [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, 176 patients started on insulin aspart ± OGLD, of which 165 (93.8%) were insulin naïve and 11 (6.2%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events reduced in both insulin naïve (from 1.7 events/patient-year to 0.0 events/patient-year) and insulin user (from 2.4 events/patient-year to 0.0 events/patient-year) user groups. Body weight decreased and quality of life improved at the end of the study [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].
| Conclusion | | |
Our study reports improved glycaemic control (HbA 1 c, FPG, PPPG) and quality of life following 24 weeks of treatment with any of the insulin analogues (biphasic 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. An increase in body weight was noted for the total cohort. 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 Delhi, 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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