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

Translated title of the contribution: An open multicentre trial with insulin analogue mix-50 NPL in patients with poorly compensated type 2 diabetes

Sandro Gentile, M. Amodio, M. Agrusta, P. Calatola, E. Del Vecchio, P. Memoli, E. Bellinfante, G. Catapano, P. Castagnola, G. Corigliano, A. Di Matteo, A. Foglia, G. Guarino, L. Lo Conte, L. Lucibelli, C. Martino, M. Colacurcio, D. Pascucci, A. Perrelli, C. ScuriniG. Sodo, S. Turco

Research output: Contribution to journalArticlepeer-review


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 HbA1c > 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 HbA1c; 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) HbA1c 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 HbA1c 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 12th 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.

Translated title of the contributionAn open multicentre trial with insulin analogue mix-50 NPL in patients with poorly compensated type 2 diabetes
Original languageItalian
Pages (from-to)65-70
Number of pages6
JournalGiornale Italiano di Diabetologia e Metabolismo
Issue number2
Publication statusPublished - Jun 2008

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism


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