Abstract
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.
| Original language | Italian |
|---|---|
| Pages (from-to) | 65-70 |
| Number of pages | 6 |
| Journal | Giornale Italiano di Diabetologia e Metabolismo |
| Volume | 28 |
| Issue number | 2 |
| Publication status | Published - Jun 2008 |
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ASJC Scopus subject areas
- Endocrinology
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
Cite this
Studio multicentrico in aperto con analogo insulinico mix-50 NPL in diabetici tipo 2 scompensati. / Gentile, Sandro; Amodio, M.; Agrusta, M.; Calatola, P.; Del Vecchio, E.; Memoli, P.; Bellinfante, E.; Catapano, G.; Castagnola, P.; Corigliano, G.; Di Matteo, A.; Foglia, A.; Guarino, G.; Lo Conte, L.; Lucibelli, L.; Martino, C.; Colacurcio, M.; Pascucci, D.; Perrelli, A.; Scurini, C.; Sodo, G.; Turco, S.
In: Giornale Italiano di Diabetologia e Metabolismo, Vol. 28, No. 2, 06.2008, p. 65-70.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Studio multicentrico in aperto con analogo insulinico mix-50 NPL in diabetici tipo 2 scompensati
AU - Gentile, Sandro
AU - Amodio, M.
AU - Agrusta, M.
AU - Calatola, P.
AU - Del Vecchio, E.
AU - Memoli, P.
AU - Bellinfante, E.
AU - Catapano, G.
AU - Castagnola, P.
AU - Corigliano, G.
AU - Di Matteo, A.
AU - Foglia, A.
AU - Guarino, G.
AU - Lo Conte, L.
AU - Lucibelli, L.
AU - Martino, C.
AU - Colacurcio, M.
AU - Pascucci, D.
AU - Perrelli, A.
AU - Scurini, C.
AU - Sodo, G.
AU - Turco, S.
PY - 2008/6
Y1 - 2008/6
N2 - 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.
AB - 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.
KW - Diabetes mellitus
KW - Insulin analogues
KW - Mix-50
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M3 - Articolo
VL - 28
SP - 65
EP - 70
JO - Giornale Italiano di Diabetologia
JF - Giornale Italiano di Diabetologia
SN - 1593-6104
IS - 2
ER -