Glycaemic control in type 1 diabetic patients using optimised insulin aspart or human insulin in a randomised multinational study.

Full Abstract

Insulin aspart (IAsp), is a rapid-acting analogue of human insulin (HI), for use in the meal related treatment of diabetes mellitus. The degree of glycaemic control achieved by IAsp in comparison with HI after algorithm-driven dose optimisation was tested over 3 months. The prospective, multicentre, randomised, open-label study with parallel groups was performed in 48 centres in 11 countries and included 423 basal-bolus treated patients with Type 1 diabetes. Main outcome measures were blood glucose control assessed by HbA1c, nine-point self-monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia and adverse events. An algorithm-driven increase occurred in the dose and number of daily injections of basal insulin, particularly in the IAsp group. After 12 weeks of treatment, HbA1c was significantly lower in IAsp compared to HI treated subjects by 0.17 (95% CI 0.30-0.04) (P<0.05). Comparison of the blood glucose profiles showed lower blood glucose levels with IAsp after breakfast (mean 8.4 vs 10.1 mmol/l; P<0.0001) and dinner (8.2 vs 9.3 mmol/l; P<0.01). There were no differences between treatments in the incidence of hypoglycaemic episodes or in the adverse event profiles. The WHO Diabetes Treatment Satisfaction Questionnaire score for perceived hyperglycaemia was lower with Iasp (P=0.005), and patients found the insulin aspart treatment more flexible (P=0.022). The current study underlines the need for optimising the basal insulin regimen in order to take full advantage of the pharmacodynamics of IAsp.

Author information

Author/s: Tamás, G (G); Marre, M (M); Astorga, R (R); Dedov, I (I); Jacobsen, J (J); Lindholm, A (A); Insulin Aspart Study Goup;

Affiliation: National Centre for Diabetes Care, 1st Department of Medicine, Diabetes Unit, Semmelweis University, Medical Faculty, Korányi Sándor utca 2A, H-1083, Budapest, Hungary. tamgyu(-atsign-)bell.sote.hu

Journal and publication information

Publication Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial

Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract), published in Ireland. (Language: eng)

Reference: 2001-Nov; vol 54 (issue 2) : pp 105-14

Dates: Created 2001/10/19; Completed 2002/01/16; Revised 2009/09/10;

PMID: 11640994, status: MEDLINE (last retrieval date: 9/10/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.