Efficacy and Safety of Inhaled Insulin (Exubera) Compared With Subcutaneous Insulin Therapy in Patients With Type 2 Diabetes
Results of a 6-month, randomized, comparative trial
- Priscilla A. Hollander, MD1,
- Lawrence Blonde, MD2,
- Richard Rowe, MD3,
- Adi E. Mehta, MD4,
- Joseph L. Milburn, MD5,
- Kenneth S. Hershon, MD6,
- Jean-Louis Chiasson, MD7,
- Seymour R. Levin, MD8 and
- for the Exubera Phase III Study Group
- 1Baylor University Medical Center, Dallas, Texas
- 2Ochsner Clinic, New Orleans, Louisiana
- 3Division of Endocrinology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
- 4Cleveland Clinic Foundation, Cleveland, Ohio
- 5North Texas Health Care Associates, Irving, Texas
- 6North Shore Diabetes and Endocrine Associates, New Hyde Park, New York
- 7Research Center, Department of Medicine, Centre Hospitalier de l’Université de Montréal, Campus Hôtel-Dieu, University of Montreal, Montreal, Quebec, Canada
- 8West Los Angeles VA Medical Center, Los Angeles, California
- Address correspondence and reprint requests to Priscilla Hollander, MD, Baylor University Medical Center, Endocrinology Center, 3600 Gaston Ave., Wadley Tower, Dallas, TX 75246. E-mail: priscilh{at}baylorhealth.edu
Abstract
OBJECTIVE— Glycemic control using inhaled, dry-powder insulin plus a single injection of long-acting insulin was compared with a conventional regimen in patients with type 2 diabetes, which was previously managed with at least two daily insulin injections.
RESEARCH DESIGN AND METHODS— Patients were randomized to 6 months’ treatment with either premeal inhaled insulin plus a bedtime dose of Ultralente (n = 149) or at least two daily injections of subcutaneous insulin (mixed regular/NPH insulin; n = 150). The primary efficacy end point was the change in HbA1c from baseline to the end of study.
RESULTS— HbA1c decreased similarly in the inhaled (−0.7%) and subcutaneous (−0.6%) insulin groups (adjusted treatment group difference: −0.07%, 95% CI −0.32 to 0.17). HbA1c <7.0% was achieved in more patients receiving inhaled (46.9%) than subcutaneous (31.7%) insulin (odds ratio 2.27, 95% CI 1.24–4.14). Overall hypoglycemia (events per subject-month) was slightly lower in the inhaled (1.4 events) than in the subcutaneous (1.6 events) insulin group (risk ratio 0.89, 95% CI 0.82–0.97), with no difference in severe events. Other adverse events, with the exception of increased cough in the inhaled insulin group, were similar. No difference in pulmonary function testing was seen. Further studies are underway to assess tolerability in the longer term. Insulin antibody binding increased more in the inhaled insulin group. Treatment satisfaction was greater in the inhaled insulin group.
CONCLUSIONS— Inhaled insulin appears to be effective, well tolerated, and well accepted in patients with type 2 diabetes and provides glycemic control comparable to a conventional subcutaneous regimen.
- DLCO, carbon monoxide diffusing capacity
- FEV1, forced expiratory volume in 1 s
- FPG, fasting plasma glucose
- FVC, forced vital capacity
- LOCF, last observation carried forward
- PFT, pulmonary function test
- PPG, postprandial plasma glucose
- SMBG, self-monitoring of blood glucose
- TLC, total lung capacity
Footnotes
-
L.B. has served as a consultant for or received honoraria from and also received grant support from Amilyn Pharmaceuticals, Aventis, BD, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Merck, Novo Nordisk, Novartis, and Pfizer and has also received only honoraria from Lifescan, Merck/Shering-Plough, Takeda Pharmaceuticals, and Wyeth. J.-L.C. has received honoraria from Aventis Pharma and has received honoraria and research support from Pfizer Canada. P.A.H. is a member of the advisory board for and has received research support from Pfizer Pharmaceuticals. S.R.L. has received research support from Pfizer and Aventis. R.R. is a member of the Diabetes Advisory Group for Atlantic Canada for GlaxoSmithKline; has received honoraria from GlaxoSmithKline, Eli Lilly, Novo Nordisk, and the Canadian Diabetes Association; and has received research support from Pfizer, Merck Frosst, Novo Nordisk, and AstraZeneca. A.E.M. has received consulting fees and honororaria from Aventis, GlaxoSmithKline, Merck, Novartis, and Pfizer; and has received research support from Pfizer and Aventis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
-
- Accepted July 15, 2004.
- Received April 23, 2004.
- DIABETES CARE
