Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Southwest 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 patients enrolled from southwest Saudi Arabia.

Results:

A total of 2561 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 987), insulin detemir (n = 1121), insulin aspart (n = 21), basal insulin plus insulin aspart (n = 280) and missing or other insulin combinations (n = 152). At baseline glycaemic control was poor for both insulin naïve (mean HbA₁c: 9.9%) and insulin user (mean HbA₁c: 9.5%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA₁c (insulin naïve: −2.5%, insulin users: −2.2%). Major hypoglycaemic events did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups.

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 patients enrolled from southwest Saudi Arabia.

MATERIALS AND METHODS

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

RESULTS

A total of 2561 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 (43.8%) started on or switched to insulin detemir. Other groups were insulin aspart (n = 21), basal insulin plus insulin aspart (n = 280), Biphasic insulin aspart (n = 121) and other insulin combinations (n = 17).

Table 1.

Overall demographic data

After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 5.3 events/patient-year to 1.9 events/patient-year in insulin user group whereas overall hypoglycaemia increased from 0.8 events/patient-year to 1.8 events/patient-year in the insulin naïve group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. Major hypoglycaemic events did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups. Body weight decreased at the end of the study. Blood pressure and lipid profile improved after 24 weeks 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, 987 patients started on biphasic insulin aspart ± OGLD, of which 483 (48.9%) were insulin naïve and 504 (51.1%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes reduced from 4.2 events/patient-year to 1.8 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.8 events/patient-year to 1.7 events/patient-year in insulin naïve group. Body weight decreased at 24 weeks [Tables 5 and 6].

Table 5.

Biphasic insulin aspart±oral glucose-lowering drug safety data

Table 6.

Insulin dose

All aspects 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, 280 patients started on basal + insulin aspart ± OGLD, of which 70 (25%) were insulin naïve and 210 (75%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 1.9 events/patient-year to 1.0 events/patient-year in insulin naïve group and from 6.7 events/patient-year to 2.5 events/patient-year in insulin user group. Body weight decreased after 24 weeks in insulin naïve group [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 switched to 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, 1121 patients started on insulin detemir ± OGLD, of which 982 (87.6%) were insulin naïve and 139 (12.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 3.6 events/patient-year to 1.3 events/patient-year in insulin user group while hypoglycaemic events increased from 0.7 events/patient-year to 2.1 events/patient-year in insulin naïve group. A slight decrease in body weight was observed for both the groups at the end of 24 weeks [Table 11].

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, 21 patients started on insulin aspart ± OGLD of which 17 (80.9%) were insulin naïve and 4 (19.1%) were insulin users. Hypoglycaemia remained nil similar to that of baseline for both the groups. After 24 weeks of treatment, a decrease in body weight was observed in the insulin naïve group [Table 14].

Table 14.

Insulin aspart±oral glucose-lowering drug safety data

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 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. Major hypoglycaemic events did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups. A small weight reduction was also observed for the overall 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 southwest Saudi Arabia.