Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Indonesian cohort of the A₁chieve study.

AIM

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian type 2 diabetes patients switched from biphasic human insulin 30 (BHI 30) as a sub-analysis of the A₁chieve study.

METHODS

Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician.

RESULTS

A total of 244 patients with mean age ± SD 55.6 ± 9.5 years, BMI 24.6 ± 3.8 kg/m(2), and mean diabetes duration 7.8 ± 5.7 years were included. The mean pre-study BHI 30 dose was 0.56 ± 0.25 IU/kg and the baseline BIAsp 30 dose was 0.60 ± 0.26 U/kg titrated up to 0.65 ± 0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8 ± 1.2% at baseline to 7.3 ± 0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0 ± 11.6 points, p < 0.001).

CONCLUSION

Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.