Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from North and the oriental region of Morocco 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 Oriental, Morocco.

Results:

A total of 180 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 = 146), insulin detemir (n = 22), insulin aspart (n = 6), basal insulin plus insulin aspart (n = 2) and other insulin combinations (n = 4). At baseline glycaemic control was poor for both insulin naïve (mean HbA₁c: 9.0%) and insulin user (mean HbA₁c: 8.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA₁c (insulin naïve: −1.7%, insulin users: −1.6%). SADRs including major hypoglycaemia 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

Diabetes prevalence in Morocco is estimated to be 6.4%.[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 Oriental, Morocco.

MATERIALS AND METHODS

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

RESULTS

A total of 180 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 (81.1%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 22), insulin aspart (n = 6), basal insulin plus insulin aspart (n = 2) and other insulin combinations (n = 4).

Table 1.

Overall demographic data

After 24 weeks of treatment, overall hypoglycaemia decreased for both insulin user (from 30.1 events/patient-year to 13.8 events/patient-year) and insulin naïve (from 24.9 events/patient-year to 12.7 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. Also a decrease in body weight was observed for both the groups at 24 weeks [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]. More than 20.0% of patients achieved HbA₁c < 7.0% at week 24.

Table 4.

Overall efficacy data

Biphasic insulin aspart ± OGLD

Of the total cohort, 146 patients started on biphasic insulin aspart ± OGLD, of which 95 (65.1%) were insulin naïve and 51 (34.9%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes increased for both the groups (insulin naïve: from 26.4 events/patient-year to 14.7 events/patient-year and insulin users: from 29.6 events/patient-year to 14.1 events/patient-year). A decrease in body weight was observed for both the groups. Quality of life improved 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, 2 patients started on or were switched to basal + insulin aspart and both of them were insulin users.

Insulin detemir ± OGLD

Of the total cohort, 22 patients started on insulin detemir ± OGLD, of which 17 (77.3%) were insulin naïve and 5 (22.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events decreased for both insulin naïve (from 0.4 events/patient-year to 0.6 events/patient-year) and insulin user (from 2.9 events/patient-year to 1.9 events/patient-year) group. Quality of life improved at the end of 24 weeks [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, 6 patients started on insulin aspart ± OGLD of which 1 (16.7%) was insulin naïve and 5 (83.3%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 13.0 events/patient-year to 0.0 events/patient-year for insulin user group [Tables 11 and 12].

Table 11.

Insulin aspart±oral glucose-lowering drug safety data

Table 12.

Insulin dose

CONCLUSION

Our study reports improved glycaemic control following 24 weeks of treatment with any of the insulin analogues (biphasic insulin aspart; insulin detemir; insulin aspart) with or without OGLD. SADRs including major hypoglycaemia did not occur in any of the study patients. Bodyweight decreased and quality of life improved after 24 weeks in the total 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 Oriental Morocco.