Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Oman 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 Oman.

Results:

A total of 349 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 = 121), insulin detemir (n = 171), insulin aspart (n = 2), basal insulin plus insulin aspart (n = 38) and other insulin combinations (n = 17). At baseline glycaemic control was poor for both insulin naïve (mean HbA₁c: 9.2%) and insulin user (mean HbA₁c: 8.8%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA₁c (insulin naïve: −2.1%, insulin users: −1.6%). 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 and no weight gain.

INTRODUCTION

With 138 thousand people with diabetes, diabetes prevalence in Oman is estimated to be 7.6%.[1] Fear of hypoglycaemia and gain in body weight act as 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 Oman.

MATERIALS AND METHODS

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

RESULTS

A total of 349 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 (48.99%) started on or switched to insulin detemir. Other groups were insulin aspart (n = 2), basal insulin plus insulin aspart (n = 38), Biphasic insulin aspart (n = 121) and other insulin combinations (n = 17). After 24 weeks of treatment, overall hypoglycaemic events reduced from 1.1 events/patient-year to 0.9 events/patient-year in insulin naive group and from 12.0 events/patient-year to 3.2 events/patient-year in insulin user group. 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 the study patients. Body weight decreased and overall lipid profile improved at week 24 in complete cohort [Tables 2 and 3].

Table 1.

Overall demographic data

Table 2.

Overall safety data

Table 3.

Insulin dose

All parameters of glycaemic control improved from baseline to study end in the total cohort. Approximately, more than half of the patients achieved HbA₁c < 7.0% at week 24 [Table 4].

Table 4.

Overall efficacy data

Biphasic insulin aspart ± OGLD

Of the total cohort, 121 patients started on biphasic insulin aspart ± OGLD, of which 88 (72.7%) were insulin naïve and 33 (27.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 13.4 events/patient-year to 3.9 events/patient-year in insulin user group and increased from 1.4 events/patient-year to 0.9 events/patient-year in insulin naive group. A decrease in body weight was also observed at the end of the study [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, 38 patients started on basal + insulin aspart ± OGLD, of which 8 (21.1%) were insulin naïve and 30 (78.9%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 13.4 events/patient-year to 5.2 events/patient-year in insulin user group and increased from 0.0 events/patient-year to 1.6 events/patient-year in insulin naive group. Body weight decreased at the end of the study [Tables 8 and 9].

Table 8.

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

Table 9.

Insulin dose

All aspects of glycaemic control improved from baseline to study end in those who started on or 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, 171 patients started on insulin detemir ± OGLD, of which 131 (76.6%) were insulin naïve and 40 (23.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 1.3 events/patient-year to 0.5 events/patient-year in insulin naive group and from 11.1 events/patient-year to 2.0 events/patient-year in insulin user group. A small decrease in body weight also observed at 24 weeks [Tables 11 and 12].

Table 11.

Insulin detemir±oral glucose-lowering drug safety data

Table 12.

Insulin dose

All aspects of glycaemic control improved from baseline to study end in those who started on or 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, 2 patients started on insulin aspart ± OGLD and both were insulin users. Similar to baseline, hypoglycaemia remained nil at 24 weeks in insulin user group. A decrease in body weight was also observed in insulin user group. All aspects of glycaemic control improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin user group.

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. Patient compliance was good with insulin analogues due to less painful injection and decreased fear of hypoglycaemia. 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 Oman.