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

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 Andhra Pradesh, India. Results: A total of 3077 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 = 2452), insulin detemir ( n = 308), insulin aspart ( n = 226), basal insulin plus insulin aspart ( n = 21) and other insulin combinations ( n = 68). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 8.9%) 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: − 1.2%, insulin users: − 1.1%). 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.

After 24 weeks of treatment, overall hypoglycaemic events reduced in both insulin naïve (from 0.9 events/ patient-year to 0.0 events/patient-year) and insulin user (from 0.6 events/patient-year to 0.0 events/ patient-year) groups. No hypoglycaemic episode in insulin naive group even at 24 weeks suggests low event rate than insulin users at baseline. A decrease in body weight was also observed at the end of the study. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased while overall lipid profi le and quality of life improved at week 24 in the total cohort [ Tables 2 and 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, 2452 patients started on biphasic insulin aspart ± OGLD, of which 1939 (79.1%) were insulin naïve and 513 (20.9%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemia reduced to nil for both insulin naïve (0.9 events/patient-year at baseline) and insulin user (0.7 events/patient-year at baseline) groups. Body weight decreased and quality of life improved after 24 weeks [Tables 5 and 6].
All parameters of glycaemic control improved from baseline to study end in those who started on or were S544     switched to biphasic insulin aspart for both insulin naïve and insulin user groups [ Table 7].

Basal + insulin aspart ± OGLD
Of the total cohort, 21 patients started on basal + insulin aspart ± OGLD, of which 11 (52.4%) were insulin naïve and 10 (47.6%) were insulin users. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events reduced from 1.2 events/patient-year to zero events in insulin naive group, whereas hypoglycaemia was nil in insulin user group similar to baseline. A decrease in body weight and improvement in quality of life was also observed at 24 weeks [Tables 8 and 9].
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].

Insulin detemir ± OGLD
Of the total cohort, 308 patients who started on insulin detemir ± OGLD, of which 250 (81.2%) were insulin naïve and 58 (18.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced to nil for both insulin naïve (0.8 events/patient-year at baseline) and insulin user   Tables 11 and 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, 226 patients started on insulin aspart ± OGLD, of which 129 (57.1%) were insulin naïve and 97 (42.9%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart hypoglycaemia reduced to zero for both insulin naïve (1.1 events/patient-year at baseline) and insulin user (insulin users: 0.4 events/patient-year at baseline) groups. A decrease in body weight and improvement in quality of life was observed at 24 weeks [Tables 14 and 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 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 after 24 week of treatment. A decrease in body weight was observed for all the four regimens. Though the fi ndings are limited by number of patients, still the trend indicates that insulin analogues can be considered effective and possess a safe profi le for treating type 2 diabetes in Andhra Pradesh, India.