Availability of Inhaled Insulin Promotes Greater Perceived Acceptance of Insulin Therapy in Patients With Type 2 Diabetes
- Nick Freemantle, PHD1,
- Lawrence Blonde, MD2,
- Didier Duhot, MD3,
- Marcus Hompesch, MD4,
- Robert Eggertsen, MD, PHD5,
- F.D. Richard Hobbs, FRCGP, FRCP, FMEDSCI1,
- Luc Martinez, MD3,
- Stuart Ross, MB, CHB, FRCP6,
- Björn Bolinder, BA7 and
- Elmar Stridde, MD8
- 1Department of Primary Care & General Practice, University of Birmingham, Birmingham, U.K.
- 2Ochsner Clinic Foundation, New Orleans, Louisiana
- 3Société Française de Médecine Générale, Issy les Moulineaux, France
- 4Profil Institute for Clinical Research, Chula Vista, California
- 5Department of Primary Health Care, Göteborg University, Göteborg, Sweden
- 6Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
- 7Aventis Pharma, Bridgewater, New Jersey
- 8Pfizer, Karlsruhe, Germany
- Address correspondence and reprint requests to Nick Freemantle, PhD, Professor of Clinical Epidemiology & Biostatistics, Department of Primary Care and General Practice, Primary Care Clinical Sciences Building, University of Birmingham Edgbaston, Birmingham B15 2TT U.K. E-mail: n.freemantle{at}bham.ac.uk
Inhaled insulin (INH, Exubera) is under investigation for preprandial treatment of patients with type 1 and type 2 diabetes (1–3). This dry-powder insulin formulation is delivered by aerosol, permitting the noninvasive administration of rapid-acting insulin (4). Preliminary studies have shown that INH provides reproducible and effective control of glycemia (1,5–7). This randomized controlled trial examined the extent to which the availability of INH affects the perceived acceptability of insulin therapy among patients with type 2 diabetes who failed to achieve target glycemia on current therapy.
RESEARCH DESIGN AND METHODS
Male or female participants (n = 779) aged 35–80 years with at least 3 months duration of type 2 diabetes and a HbA1c >8%, despite current therapy, were recruited from seven countries. Permitted current therapy included dietary measures and/or oral antidiabetic agents (OADs). Patients receiving insulin injections, smokers, or those who had significant pulmonary diseases were excluded. All patients gave informed consent, and local research ethics review boards approved the study.
Participants were randomly assigned to receive either educational information about the potential risks and benefits of all currently licensed treatment options only (OADs and/or subcutaneous insulin, n = 388) or information about the potential risks and benefits of licensed treatments and INH (n = 391). …