Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes: A randomized, stratified, double-blind and cross-over trial

Gabriele Perriello, S. Pampanelli, F. Porcellati, A. Avogaro, E. Bosi, G. Petrella, S. Squatrito, S. Furneri, G. Marra, L. Vitali, M. Previti, D. Cucinotta

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)606-611
Number of pages6
JournalDiabetic Medicine
Volume22
Issue number5
DOIs
Publication statusPublished - May 2005

Fingerprint

Insulin Aspart
Cross-Over Studies
Type 2 Diabetes Mellitus
Meals
Insulin
Insulin, Regular, Human
Serum
Glucose
Placebos
Pharmacokinetics

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 journalArticle

Perriello, G, Pampanelli, S, Porcellati, F, Avogaro, A, Bosi, E, Petrella, G, Squatrito, S, Furneri, S, Marra, G, Vitali, L, Previti, M & Cucinotta, D 2005, 'Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes: A randomized, stratified, double-blind and cross-over trial', Diabetic Medicine, vol. 22, no. 5, pp. 606-611. https://doi.org/10.1111/j.1464-5491.2005.01473.x
Perriello, Gabriele ; Pampanelli, S. ; Porcellati, F. ; Avogaro, A. ; Bosi, E. ; Petrella, G. ; Squatrito, S. ; Furneri, S. ; Marra, G. ; Vitali, L. ; Previti, M. ; Cucinotta, D. / Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes : A randomized, stratified, double-blind and cross-over trial. In: Diabetic Medicine. 2005 ; Vol. 22, No. 5. pp. 606-611.
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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.

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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.

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