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Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes: a randomized, stratified, double‐blind and cross‐over trial
Author(s) -
Perriello G.,
Pampanelli S.,
Porcellati F.,
Avogaro A.,
Bosi E.,
Petrella G.,
Squatrito S.,
Furneri S.,
Marra G.,
Vitali L.,
Previti M.,
Cucinotta D.
Publication year - 2005
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2005.01473.x
Subject(s) - insulin aspart , medicine , insulin , placebo , endocrinology , type 2 diabetes , diabetes mellitus , area under the curve , pharmacodynamics , meal , type 1 diabetes , pharmacokinetics , postprandial , alternative medicine , pathology
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.