GLYCAEMIC CONTROL, SAFETY AND TREATMENT SATISFACTION IN ROMANIAN SUBJECTS WITH TYPE 2 DIABETES TREATED WITH BIPHASIC INSULIN ASPART 30

Abstract

This 6-month, prospective, open-labelled, uncontrolled, observational study involving 28 centres across Romania evaluated the utility of biphasic insulin aspart 30 (BIAsp30; NovoMix® 30) in routine clinical practice. Subjects with type 2 diabetes inadequately controlled on their previous therapy were enrolled into the study and prescribed with BIAsp30 as monotherapy, or in combination with oral hypoglycaemic agents. Among 912 subjects available for analysis, treatment with BIAsp30 was associated with baseline reductions in HbA1c of 1.78 ± 1.38% and 2.64 ± 1.81% at 3 and 6 months, respectively. Reductions in other glycaemic parameters (FPG and PPPG) from baseline were also observed at 3 and 6 months of BIAsp30 treatment. The proportion of subjects reporting hypoglycaemic episodes was 24.9%, 27.2% and 22.0% at baseline, 3 and 6 months, respectively. Nonetheless, there was a reduction in the rate of major hypoglycaemic episodes between baseline and the end of the study, from 0.688 to 0.091 episodes per patient year. Only one case of an adverse drug reaction (ADR) was suspected during the course of the study, however, under-reporting of ADRs by the participating centres cannot be ruled out. The majority (>90%) of subjects were perceived as being either “very satisfied” or “satisfied” with BIAsp30 over previous treatment, and when the treating physicians were asked to rate how satisfied they were with BIAsp30 over their subject’s previous treatment, the majority of responses (>90%) were also either “very satisfied” or “satisfied”, at both 3 and 6 months of treatment.