Indian Journal of Endocrinology and Metabolism

ORIGINAL ARTICLE
Year
: 2013  |  Volume : 17  |  Issue : 8  |  Page : 579--583

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


Satinath Mukhopadhyay1, Nilanjan Sengupta2, Sujoy Ghosh1,  
1 IPGME and R and SSKM Hospital, Kolkata, West Bengal, India
2 NRS Medical College and Hospital, Kolkata, West Bengal, India

Correspondence Address:
Satinath Mukhopadhyay
IPGME and R and SSKM Hospital, Kolkata
India

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, 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from West Bengal, India. Results: A total of 1133 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 = 897), insulin detemir (n = 94), insulin aspart (n = 90), basal insulin plus insulin aspart (n = 28) and other insulin combinations (n = 19). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 8.5%) and insulin user (mean HbA 1 c: 8.9%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA 1 c (insulin naïve: −1.3%, insulin users: −1.6%). 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.



How to cite this article:
Mukhopadhyay S, Sengupta N, Ghosh S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the West Bengal cohort of the A 1 chieve study.Indian J Endocr Metab 2013;17:579-583


How to cite this URL:
Mukhopadhyay S, Sengupta N, Ghosh S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the West Bengal cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 Jun 20 ];17:579-583
Available from: https://www.ijem.in/text.asp?2013/17/8/579/122142


Full Text

 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 West Bengal, India.

 Materials and Methods



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

 Results



A total of 1133 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 (79.2%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 94), insulin aspart (n = 90), basal insulin plus insulin aspart (n = 28) and other insulin combinations (n = 19).{Table 1}

After 24 weeks of treatment, overall hypoglycaemic events reduced from 6.9 events/patient-year to 0.9 events/patient-year in insulin users whereas overall hypoglycaemia increased from 0.2 events/patient-year to 0.7 events/patient-year in insulin naive group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still 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 while overall lipid profile and quality of life improved at week 24 in the total cohort but the findings were limited by number of observations [Table 2] and [Table 3].{Table 2}{Table 3}

All parameters of glycaemic control improved from baseline to study end in the total cohort [Table 4].{Table 4}

Biphasic insulin aspart ± OGLD

Of the total cohort, 897 patients started on biphasic insulin aspart ± OGLD, of which 769 (85.7%) were insulin naïve and 128 (14.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events decreased from 7.7 events/patient-year to 1.1 events/patient-year in insulin user group while hypoglycaemia increased from 0.2 events/patient-year to 0.8 events/patient-year in insulin naive group. A small increase in body weight was observed. Quality of life improved after 24 weeks [Table 5] and [Table 6].{Table 5}{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}

Basal + insulin aspart ± OGLD

Of the total cohort, 28 patients started on basal + insulin aspart ± OGLD, of which 15 (53.6%) were insulin naïve and 13 (46.4%) were insulin users. After 24 weeks of starting or switching to Biphasic insulin aspart, hypoglycaemic events remained nil in both insulin user and naïve group similar to that of baseline. Quality of life improved at the end of the 24 weeks [Table 8] and [Table 9].{Table 8}{Table 9}

Mean HbA 1 c and FPG value 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}

Insulin detemir ± OGLD

Of the total cohort, 94 patient started on insulin detemir ± OGLD, of which 82 (87.2%) were insulin naïve and 12 (12.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.8 events/patient-year to 0.4 events/patient-year in insulin naive group, whereas hypoglycaemia increased from 1.1 events/patient-year to 1.3 events/patient-year in insulin user group. Quality of life improved after 24 weeks [Table 11] and [Table 12].{Table 11}{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].{Table 13}

Insulin aspart ± OGLD

Of the total cohort, 90 patients started on insulin aspart ± OGLD was 90, of which 85 (94.4%) were insulin naïve and 5 (5.6%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart, hypoglycaemic events decreased from 31.1 events/patient-year to 0.0 events/patient-year in insulin users while hypoglycaemia increased from 0.0 events/patient-year to 0.2 events/patient-year in insulin naive group. An increase in body weight was observed for insulin user group [Table 14] and [Table 15].{Table 14}{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 insulin naïve group while mean HbA 1 c and FPG values improved in the insulin user group [Table 16].{Table 16}

 Conclusion



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. Overall, a small increase in body weight was observed for both insulin naïve and users group. SADRs including major hypoglycaemic events or episodes 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 West Bengal, India.

References

1Wild 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.
2Shetty P. Public health: India's diabetes time bomb. Nature 2012;485:S14-6.
3Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.
4Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.
5Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve 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.