Objective: IMPROVE study was designed to assess the safety and effectiveness of NovoMix30® in type 2 diabetes subjects under normal clinical practice conditions.
Methods: This large multi-national, open label, prospective, 6 month long observational study captured data for above 50 000 patients started on NovoMix30® with/without oral anti-diabetic drugs (OADs)/other insulin. This paper analyses safety data of 17 995 patients constituting Indian cohort of IMPROVETM study.
Results: 16 391 & 16 398 patients have been evaluated for incidence of major and minor hypoglycemic events respectively. There was reduction of 0.124 major hypoglycemic events/patient year (EPY) at the end of 6 months of NovoMix30 therapy (baseline 0.129 EPY, final 0.005 EPY, P<0.001). Patients taking OAD alone at baseline and those shifted from other insulins±OAD showed reduction of 0.050 EPY (P<0.001) and 0.327 EPY (P<0.001) respectively, while treatment naïve patients experienced no such events.
Minor hypoglycemic events were reduced by 1.92 EPY (P< 0.001) as compared to baseline (3.08 EPY). NovoMix30® therapy was associated with reduction of 61.9% (P<0.001) and 64.1% (P<0.001) in day time and nocturnal minor hypoglycemic events respectively.
A mean reduction of 0.3 kg (P<0.001) body weight in all patients with 0.9 kg (P<0.001) decrement in treatment naïve patients was noted at the end of 6 months.
Eight serious adverse drug reactions (SADR) including major hypoglycemia and 13 adverse drug reactions (ADR) were reported in 17 995 patients during the study period.
Conclusion: IMPROVETM study confirmed the safety of NovoMix30® in real life clinical practice, with lesser incidence of hypoglycemia and weight loss.
25 - 29 Apr 2009
European Society of Endocrinology