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

Abstract

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 participants enrolled from Taif, Saudi Arabia.

Results:

A total of 791 subjects were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients were started on or were switched to biphasic insulin aspart (n = 238), insulin detemir (n = 325), insulin aspart (n = 9), basal insulin plus insulin aspart (n = 85) and other insulin combinations (n = 127). At baseline glycaemic control was poor for both insulin naïve (mean HbA₁c: 9.7%) and insulin user (mean HbA₁c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA₁c (insulin naïve: −2.3%, insulin users: −2.6%). SADRs including major hypoglycaemic events did not occur in the study patients.

Conclusion:

Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

INTRODUCTION

2.7 million people are estimated to have diabetes in Saudi Arabia, with estimated prevalence of 16.2%.[1] Fear of hypoglycaemia and gain in body weight are barriers for initiation of insulin therapy.[2] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypoglycaemia and favourable weight change.[3] 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.[4] This short communication presents the results for participants enrolled from Taif, Saudi Arabia.

MATERIALS AND METHODS

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

RESULTS

A total of 791 subjects were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin user is shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (41.1%) were started on or were switched to insulin detemir. Other groups were biphasic insulin aspart (n = 238), insulin aspart (n = 9), basal insulin plus insulin aspart (n = 85) and other insulin combinations (n = 127).

Table 1.

Overall demographic data

After 24 weeks of treatment, overall hypoglycaemia reduced for both insulin naïve (from 0.6 to 0.3 events/patient-year) and insulin user (2.3 to 0.5 events/patient-year) groups. 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. A decrease in body weight was observed after 24 weeks. Blood pressure and lipid profile improved 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, 238 patients started on biphasic insulin aspart ± OGLD, of which 131 (55%) were insulin naïve and 107 (45%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events or episodes reduced for both insulin naïve and user groups (insulin naïve: from 1.0 to 0.5 events/patient-year, insulin users: from 1.1 to 0.5 events/patient-year) [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

Basal + insulin aspart ± OGLD

Of the total cohort, 85 patients started on basal + insulin aspart ± OGLD, 28 (32.9%) were insulin naïve and 57 (67.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 7.5 to 0.2 events/patient-year in insulin user group. Hypoglycaemia was nil in insulin naïve group similar to that of baseline. A decrease in body weight was also observed in both the groups. [Tables 8 and 9]

Table 8.

Basal+insulin aspart±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 basal + insulin aspart ± OGLDs for both insulin naïve and insulin user groups [Table 10].

Table 10.

Basal+insulin aspart±oral glucose-lowering drug efficacy data

Insulin detemir ± OGLD

Of the total cohort, 325 patients started on insulin detemir ± OGLD, of which 202 (62.1%) were insulin naïve and 123 (37.9%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.7 to 0.0 events/patient-year in insulin users while hypoglycaemia increased from 0.1 to 0.3 events/patient-year in insulin naïve group [Tables 11 and 12]. Body weight decreased in both the groups.

Table 11.

Insulin detemir±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 detemir ± OGLDs for both insulin-naïve and insulin user groups [Table 13].

Table 13.

Insulin detemir±oral glucose-lowering drug efficacy data

Insulin aspart ± OGLD

Of the total cohort, 9 patients started on insulin aspart ± OGLD of which 5 (55.5%) were insulin naïve and 4 (44.5%) were insulin users. After 24 weeks of treatment, hypoglycaemic events decreased from 13.0 to 0.0 events/patient-year in insulin naïve group. Hypoglycaemia was nil in insulin user group similar to that of baseline. A decrease in body weight was noted for both insulin naïve and user groups [Tables 14 and 15].

Table 14.

Insulin aspart±oral glucose-lowering drug safety data

Table 15.

Insulin dose

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched insulin aspart ± OGLDs for both insulin naïve insulin user group [Table 16].

Table 16.

Insulin aspart±oral glucose-lowering drug efficacy data

CONCLUSION

Our study reports improved glycaemic control 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. Their administration even caused a small weight reduction. SADRs including major hypoglycaemic events did not occur in 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 in Taif, Saudi Arabia.