Efficacy of Inhaled Insulin in Patients With Type 2 Diabetes not Controlled With Diet and Exercise
A 12-week, randomized, comparative trial
- Ralph A. DeFronzo, MD1,
- Richard M. Bergenstal, MD2,
- William T. Cefalu, MD3,
- John Pullman, MD4,
- Sam Lerman, MD5,
- Bruce W. Bode, MD6,
- Lawrence S. Phillips, MD7 and
- for the Exubera Phase III Study Group
- 1University of Texas Health Science Center, San Antonio, Texas
- 2International Diabetes Center, Minneapolis, Minnesota
- 3Pennington Biomedical Research Center, Baton Rouge, Louisiana
- 4Mercury Street Medical, Butte, Montana
- 5Center for Diabetes and Endocrine Care, University of Miami, Miami, Florida
- 6Atlanta Diabetes Associates, Atlanta, Georgia
- 7Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia
- Address correspondence and reprint requests to Ralph A. DeFronzo, University of Texas Health Science Center, Diabetes Division, 7703 Floyd Curl Dr., San Antonio, TX 78284. E-mail: albarado{at}uthscsa.edu
Abstract
OBJECTIVE—Effective type 2 diabetes management requires prompt intervention if glycemic control is not achieved by nonpharmacological means. This study investigates whether inhaled insulin (INH; Exubera) can achieve target glycemic control in patients failing on diet and exercise.
RESEARCH DESIGN AND METHODS—Patients with suboptimal control on diet and exercise (HbA1c [A1C] 8–11%) were randomized to 3 months’ treatment with either INH before meals (n = 76) or rosiglitazone 4 mg twice a day (n = 69), in conjunction with a diet and exercise regimen. The primary end point was percentage of patients achieving A1C <8.0%.
RESULTS—The INH and rosiglitazone groups had comparable baseline A1C values (9.5 vs. 9.4%, respectively). Significantly more patients achieved A1C <8.0% (83 vs. 58%, adjusted odds ratio 7.14 [95% CI 2.48–20.58], P = 0.0003), A1C <7.0% (44 vs. 18%, 4.43 [1.94–10.12]), and A1C ≤6.5% (28 vs. 7.5% 5.34 [1.83–15.57]) with INH. A1C decrease was greater with INH (−2.3% vs. −1.4%, adjusted treatment group difference: −0.89% [95% CI −1.23 to −0.55]) with final mean A1C values of 7.2 and 8.0% for INH and rosiglitazone, respectively. Hypoglycemia (episodes per subject-month) was higher with INH (0.7 vs. 0.05, risk ratio 14.72 [95% CI 7.51–28.83]), with no severe hypoglycemic episodes. Pulmonary function changes were small and comparable between groups.
CONCLUSIONS—INH could be an effective therapy for people with type 2 diabetes early in the course of their disease.
- ADA, American Diabetes Association
- DLco, carbon monoxide diffusing capacity
- FEV1, forced expiratory volume in 1 s
- FFA, free fatty acid
- FPG, fasting plasma glucose
- INH, inhaled insulin
- PFT, pulmonary function test
- PPG, postprandial plasma glucose
- SMBG, self-monitoring blood glucose
Footnotes
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W.T.C. has served on an advisory panel for, has received honoraria from, and has received grant/research support from Pfizer and Aventis. J.P. has received honoraria and grant/research support from Pfizer. B.W.B. has received honoraria from Pfizer, sanofi-aventis Group, Lilly, and NovoNordisk and grant/research support from Pfizer.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted April 20, 2005.
- Received December 17, 2004.
- DIABETES CARE
