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Dose-response relation of liquid aerosol inhaled insulin in type I diabetic patients.

Brunner, G. A. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
Balent, B. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
Ellmerer, M. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
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Schaupp, L. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
Siebenhofer, A. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
Jendle, Johan, 1963- (författare)
Novo Nordisk A/S, Copenhagen, Denmark
Okikawa, J. (författare)
Aradigm Corp., Hayward, California, USA
Pieber, T. R. (författare)
Department of Internal Medicine, Karl-Franzens University, Graz, Austria
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 (creator_code:org_t)
Springer, 2001
2001
Engelska.
Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 44:3, s. 305-308
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • AIMS/HYPOTHESIS: The AERx insulin Diabetes Management system (AERx iDMS) is a liquid aerosol device that enables insulin to be administered to the peripheral parts of the lung. This study aimed to compare the pharmacokinetic and pharmacodynamic properties of insulin which is inhaled using AERx iDMS with insulin which is subcutaneously administered.METHODS: In total, 18 C-peptide negative patients with Type I (insulin-dependent) diabetes mellitus participated in this randomised, open-label, 5-period crossover trial. Human regular insulin was administered subcutaneously (0.12 U/kg body weight) or inhaled by means of the AERx iDMS (dosages 0.3, 0.6, 1.2, and 1.8 U/kg body weight). Thereafter plasma glucose was kept constant at 7.2 mmol/l for a 10-h period (glucose clamp technique).RESULTS: Inhaled insulin provided a dose-response relation that was close to linear for both pharmacokinetic (AUC-Ins(0-10 h); Cmax-Ins) and pharmacodynamic (AUC-GIR(0-10 h); GIRmax) parameters. Time to maximum insulin concentration (Tmax-Ins) and time to maximum glucose infusion rate (TGIRmax) were shorter with inhaled insulin than with subcutaneous administration. The pharmacodynamic system efficiency of inhaled insulin (AUC-GIR(0-6 h) was 12.7% (95% C.I.: 10.2-15.6).CONCLUSION/INTERPRETATION: The inhalation of soluble human insulin using the AERx iDMS is feasible and provides a clear dose response. Further long-term studies are required to investigate safety aspects, HbA1c values, incidence of hypoglycaemic events and the quality of life.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Nyckelord

Type I diabetes
inhaled insulin
pulmonary insulin
pharmacokinetics
pharmacodynamics
insulin therapy

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