Studio multicentrico in aperto con analogo insulinico mix-50 NPL in diabetici tipo 2 scompensati

Insulin treatment is required in subjects with an unsatisfactory response to the maximal dosed of oral agents (OHA). Rapid insulin analogues (AR) mimics a more physiological response to the meal than regular insulin as well as premixed preparations of rapid insulin analogues with NPL insulin could handle both rapid after-meal insulin require and basal insulin with a reduced number of insulin injections. Aim of the study was to evaluate the effects of premixed analogue (AR + NPL) mix-50 TID in type 2 diabetic subjects with HbA_1c > 7,5%. The primary endpoint was: n. of patients achieving after-meal glucose ≤180 mg/dl (target ADA); secondary endpoints: 1) n. of subjects achieving after-meal glucose ≤ 140 mg/dl (target IDF)¹; 2) level of HbA_1c; 3) frequency of hypoglycaemic episodes; 4) excursion of serum glucose levels; 5) n. of subjects in whom is necessary reduce the number of insulin injections/day. For 6 months mix-50 was administered TID to 297 DM2 subjects, 169 M and 128 F, mean values (± SD) HbA_1c 8.2 ± 0.4%, age 64 ± 12 y, BMI 27 ± kg/m², eating regularly three meals/day, starting from different treatment regimens: a) OHA alone (47%); b) OHA + NPH insulin, OHA + human + NPH/premixed human insulin (25%); c) regular human insulin alone or in combination with NPH/premixed human insulin (25%). Mix-50 was tritiated starting from 0.25-0.30 UI/kg bw, 20% at the breakfast, 50% at the principal meal and 30% at the third meal, increasing 15-20% the total dose every week, if necessary. Self-monitoring blood glucose was regularly performed to evaluate hypoglycaemic episodes. After 6-moth treatment a significant reduction (p <0.001) was observed vs baseline for HbA_1c mean values (8.4 ± 0.4 vs 70 ± 0.3, n. of patients who experienced hypoglycaemia (26 vs 10), fasting blood glucose (246 ± 87 vs 122 ± 36 mg/dl), standard deviation of blood glucose (193 vs 96). The principal endpoint was achieved in 99% and the secondary endpoint in 89% of patients, respectively. The reduction from 3 to 2/day mix-50 injections was required in 16/297 and 8/281 subjects, at the 12^th and 24 ^th week, respectively. The results clearly indicate that in DM2 poorly compensated, regularly assuming three meals/day, the administration of mix-50 TID significantly and safely improve the level of glycemic control vs OHA alone or in combination with different human/NPH insulin regimens.