title: Diabetes therapy trials with inhaled insulin.
abstract: Administration of insulin by inhalation was first attempted > 50 years ago. At that time, little was known concerning effective delivery systems and insulin formulations. The recent development of pulmonary delivery systems for the administration of insulin is driven by the reluctance of patients and their providers to initiate insulin earlier in the course of Type 2 diabetes, the desire to reduce the number of daily insulin injections for both Type 1 and 2 patients, and the recent emphasis on intensified glycaemic control including postprandial glycaemic control. The deep lung is a unique mucosal tissue having a surface area of > 100 m2 and is readily accessible both to the external environment and to drug delivery, provided that appropriate conditions are met. There have been four mid- to late-phase pulmonary insulin programmes using modern inhalation devices that will be reported in this paper. The programmes differ in the choice of delivery systems, the formulations of insulin and reported bioavailability, pharmacokinetic and glucodynamic profiles and adverse events. However, all systems successfully deliver insulin to the deep lung and biological effectiveness compares favourably with injected subcutaneous insulins.
authors.affiliation: Indiana University School of Medicine, 1120 South Drive, Fesler Hall 302, Indianapolis, USA. efineber@iupui.edu
authors.forename: Samuel Edwin
authors.initials: SE
authors.lastname: Fineberg
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000336:Aerosols; D000818:Animals; D001682:Biological Availability; D001786:Blood Glucose / Q000032:analysis; D017326:Clinical Trials, Phase III as Topic; D003920:Diabetes Mellitus / Q000188:drug therapy*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004339:Drug Compounding; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006168:Guinea Pigs; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D007330:Insulin Antibodies / Q000096:biosynthesis; D008168:Lung / Q000502:physiology; D008297:Male; D036501:Metered Dose Inhalers; D008863:Microspheres; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011208:Powders; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D051381:Rats; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000336:Aerosols; D001786:Blood Glucose; D015507:Drugs, Investigational; D006442:Glycated Hemoglobin; D007328:Insulin; D007330:Insulin Antibodies; D011208:Powders; D011994:Recombinant Proteins; C473734:Exubera