Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Trivandrum cohort of the A1chieve study.

BACKGROUND: The A1chieve, 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 Trivandrum, India.
RESULTS: A total of 528 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 = 392), insulin detemir (n = 65), insulin aspart (n = 70) and other insulin combinations (n = 1). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.9%) and insulin user (mean HbA1c: 8.1%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.4%, insulin users: -1.0%). 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.

INTRODUCTION

62.4 million Indians were reported to have type 2 diabetes mellitus (T2DM) putting India on the forefront of diabetic epidemic across globe.[12] 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] A1chieve, 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 Trivandrum, India.

MATERIALS AND METHODS

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

RESULTS

A total of 528 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin users are shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (74.2%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 65), insulin aspart (n = 70) and other insulin combinations (n = 1).

Table 1

Overall demographic data

After 24 weeks of treatment, overall hypoglycaemic events remained nil in both insulin naïve and user group similar to that of baseline. SADRs did not occur in any of the study patients. Blood pressure decreased whereas overall lipid profile and quality of life improved at week 24 in the total cohort [Tables 2 and 3].

Table 2

Overall safety data

Table 3

Insulin dose

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

Table 4

Overall efficacy data

Biphasic insulin aspart ± OGLD

Of the total cohort, 392 patients started on biphasic insulin aspart ± OGLD, of which 387 (98.7%) were insulin naïve and 5 (71.0%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events remained nil in both insulin naïve and user group similar to baseline. A slight increase in body weight was noted for insulin users. Quality of life improved after 24 weeks [Tables 5 and 6].

Table 5

Biphasic insulin aspart±oral glucose-lowering drug safety data

Table 6

Insulin dose

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

Insulin detemir ± OGLD

Of the total cohort, 65 patients were started on insulin detemir ± OGLD and all were insulin naive. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events remained nil similar to that of baseline. Body weight decreased and quality of life improved at the end of the study [Tables 8 and 9].

Table 8

Insulin detemir±oral glucose-lowering drug safety data

Table 9

Insulin dose

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for insulin-naïve group [Table 10].

Table 10

Insulin detemir±oral glucose-lowering drug efficacy data

Insulin aspart ± OGLD

Of the total cohort, 70 patients started on insulin aspart ± OGLD, of which 69 (98.6%) were insulin naïve and 1 (1.4%) was insulin user. After 24 weeks of starting or switching to insulin aspart, hypoglycaemia was nil in both insulin naïve and insulin user groups similar to baseline. Body weight decreased and quality of life improved after 24 weeks in insulin naïve group [Tables 11 and 12].

Table 11

Insulin aspart±oral glucose-lowering drug safety data

Table 12

Insulin dose

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 [Table 13].

Table 13

Insulin aspart±oral glucose-lowering drug efficacy data

CONCLUSION

Our study reports improved glycaemic control (HbA1c, 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. Overall, body weight decreased in insulin naïve group while it increased in insulin users. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients after 24 week of treatment. 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 Trivandrum, India.