Efficacy of Inhaled Insulin in Patients With Type 2 Diabetes not Controlled With Diet and Exercise

Author:

DeFronzo Ralph A.1,Bergenstal Richard M.2,Cefalu William T.3,Pullman John4,Lerman Sam5,Bode Bruce W.6,Phillips Lawrence S.7,

Affiliation:

1. University of Texas Health Science Center, San Antonio, Texas

2. International Diabetes Center, Minneapolis, Minnesota

3. Pennington Biomedical Research Center, Baton Rouge, Louisiana

4. Mercury Street Medical, Butte, Montana

5. Center for Diabetes and Endocrine Care, University of Miami, Miami, Florida

6. Atlanta Diabetes Associates, Atlanta, Georgia

7. Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia

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.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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