Safety and efficacy of switching to biphasic insulin aspart 30/70 (BIAsp 30) under the routine diabetic care in patients with type 2 diabetes: The IMPROVE™ observational study in the Gulf region

Abstract 

The IMPROVE™ study was a 26-week, multinational, open-label, non-randomized study, carried out in 11 countries.

Aim

To evaluate the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in patients with type 2 diabetes under routine clinical practice.

Study design

There were no prescribed procedures for this study except for the collection of data.

Result

Data obtained at baseline and Week 26 in patients from the Gulf region is presented. From the Gulf region, 1613 patients (61% males) were enrolled with a mean age of 50.5years and a mean BMI of 30.4kg/m². The majority of the patients (57.0%) were treated with OAD only, while 34.3% patients were previously treated with insulin ±OAD and 8.7% were treatment naive. After 26weeks of treatment, the mean HbA_1c was reduced by 1.4% from 9.3% at baseline to 7.9% at Week 26. The mean FBG was reduced by 66.6mg/dL from 212.4mg/dL at baseline to 145.8mg/dL at Week 26. No major hypoglycaemic episodes were reported as SADRs during the study. The rate of major hypoglycaemic episodes was reduced from 0.13 episodes/patient year at baseline to 0.05 episodes/patient year at Week 26. A lower risk of minor hypoglycaemia was also observed. Body weight was reduced by 0.6kg from 85.4kg at baseline to 84.7kg at Week 26.

Conclusion

BIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemic episodes and weight gain after 26weeks’ treatment in patients with type 2 diabetes from the Gulf region.

Keywords: Biphasic insulin aspart 30/70, Gulf region, Safety, Efficacy