Abstract
Aims: This randomized, multi-centre, double-blind, stratified, two period, cross-over trial was undertaken to assess the pharmacokinetics and pharmacodynamics of insulin aspart injected immediately before compared with regular human insulin injected 30 min before a Mediterranean-style meal in 37 (23 M, 14 F) patients with Type 2 diabetes. Methods: Insulin aspart or regular human insulin was given subcutaneously (0.15 U/kg) in random sequence, using a double-dummy technique (at one visit: human regular insulin at t = -30 min and placebo at t = 0; at the other visit: placebo at t = -30 min and aspart insulin at t = 0). Serum glucose and insulin concentrations (15 points) were measured after each meal for 240 min. Results: Post-prandial glycaemic excursions were 20% lower with insulin aspart (IAsp) compared with regular human insulin (HI) treatment [ratio (Iasp/HI) = 0.80, CI = (0.66-0.98), P = 0.034]. The maximum serum glucose (SG) concentration was similar for the two treatments (P = NS). The (median) time to maximum SG was 25 min shorter for IAsp compared with HI (P = 0.048). Maximum serum insulin concentration was higher after IAsp compared with HI (P = 0.023) as well as the area under the 4-h serum insulin curve (P = 0.006). Furthermore, the time to maximum serum insulin concentration was 27 min shorter after IAsp (P = 0.039), even though IAsp was injected 30 min after HI. No adverse events occurred during the trial. Conclusions: In patients with Type 2 diabetes a more favourable insulin profile and a better glycaemic control were found with IAsp injected immediately before compared with HI injected 30 min before a Mediterranean-style meal.
| Original language | English |
|---|---|
| Pages (from-to) | 606-611 |
| Number of pages | 6 |
| Journal | Diabetic Medicine |
| Volume | 22 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - May 2005 |
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Keywords
- Aspart
- Meal-time glycaemic control
- Type 2 diabetes
ASJC Scopus subject areas
- Endocrinology
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
Cite this
Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes : A randomized, stratified, double-blind and cross-over trial. / Perriello, Gabriele; Pampanelli, S.; Porcellati, F.; Avogaro, A.; Bosi, E.; Petrella, G.; Squatrito, S.; Furneri, S.; Marra, G.; Vitali, L.; Previti, M.; Cucinotta, D.
In: Diabetic Medicine, Vol. 22, No. 5, 05.2005, p. 606-611.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes
T2 - A randomized, stratified, double-blind and cross-over trial
AU - Perriello, Gabriele
AU - Pampanelli, S.
AU - Porcellati, F.
AU - Avogaro, A.
AU - Bosi, E.
AU - Petrella, G.
AU - Squatrito, S.
AU - Furneri, S.
AU - Marra, G.
AU - Vitali, L.
AU - Previti, M.
AU - Cucinotta, D.
PY - 2005/5
Y1 - 2005/5
N2 - Aims: This randomized, multi-centre, double-blind, stratified, two period, cross-over trial was undertaken to assess the pharmacokinetics and pharmacodynamics of insulin aspart injected immediately before compared with regular human insulin injected 30 min before a Mediterranean-style meal in 37 (23 M, 14 F) patients with Type 2 diabetes. Methods: Insulin aspart or regular human insulin was given subcutaneously (0.15 U/kg) in random sequence, using a double-dummy technique (at one visit: human regular insulin at t = -30 min and placebo at t = 0; at the other visit: placebo at t = -30 min and aspart insulin at t = 0). Serum glucose and insulin concentrations (15 points) were measured after each meal for 240 min. Results: Post-prandial glycaemic excursions were 20% lower with insulin aspart (IAsp) compared with regular human insulin (HI) treatment [ratio (Iasp/HI) = 0.80, CI = (0.66-0.98), P = 0.034]. The maximum serum glucose (SG) concentration was similar for the two treatments (P = NS). The (median) time to maximum SG was 25 min shorter for IAsp compared with HI (P = 0.048). Maximum serum insulin concentration was higher after IAsp compared with HI (P = 0.023) as well as the area under the 4-h serum insulin curve (P = 0.006). Furthermore, the time to maximum serum insulin concentration was 27 min shorter after IAsp (P = 0.039), even though IAsp was injected 30 min after HI. No adverse events occurred during the trial. Conclusions: In patients with Type 2 diabetes a more favourable insulin profile and a better glycaemic control were found with IAsp injected immediately before compared with HI injected 30 min before a Mediterranean-style meal.
AB - Aims: This randomized, multi-centre, double-blind, stratified, two period, cross-over trial was undertaken to assess the pharmacokinetics and pharmacodynamics of insulin aspart injected immediately before compared with regular human insulin injected 30 min before a Mediterranean-style meal in 37 (23 M, 14 F) patients with Type 2 diabetes. Methods: Insulin aspart or regular human insulin was given subcutaneously (0.15 U/kg) in random sequence, using a double-dummy technique (at one visit: human regular insulin at t = -30 min and placebo at t = 0; at the other visit: placebo at t = -30 min and aspart insulin at t = 0). Serum glucose and insulin concentrations (15 points) were measured after each meal for 240 min. Results: Post-prandial glycaemic excursions were 20% lower with insulin aspart (IAsp) compared with regular human insulin (HI) treatment [ratio (Iasp/HI) = 0.80, CI = (0.66-0.98), P = 0.034]. The maximum serum glucose (SG) concentration was similar for the two treatments (P = NS). The (median) time to maximum SG was 25 min shorter for IAsp compared with HI (P = 0.048). Maximum serum insulin concentration was higher after IAsp compared with HI (P = 0.023) as well as the area under the 4-h serum insulin curve (P = 0.006). Furthermore, the time to maximum serum insulin concentration was 27 min shorter after IAsp (P = 0.039), even though IAsp was injected 30 min after HI. No adverse events occurred during the trial. Conclusions: In patients with Type 2 diabetes a more favourable insulin profile and a better glycaemic control were found with IAsp injected immediately before compared with HI injected 30 min before a Mediterranean-style meal.
KW - Aspart
KW - Meal-time glycaemic control
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=20944440180&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=20944440180&partnerID=8YFLogxK
U2 - 10.1111/j.1464-5491.2005.01473.x
DO - 10.1111/j.1464-5491.2005.01473.x
M3 - Article
C2 - 15842516
AN - SCOPUS:20944440180
VL - 22
SP - 606
EP - 611
JO - Diabetic Medicine
JF - Diabetic Medicine
SN - 0742-3071
IS - 5
ER -