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The Effect of an Inhaled Corticosteroid on Glucose Control in Type 2 Diabetes

John L. Faul, MD, Department of Respiratory Medicine Connolly Hospital, Dublin, Ireland
Sandra R. Wilson, PhD, Palo Alto Medical Foundation, Research Institute, Palo Alto, California, USA and Division of Pulmonary and Critical Care Medicine, Stanford University, Palo Alto, California, USA
James W. Chu, MD, Division of Endocrinology and Metabolism, Stanford University School of Medicine, Palo Alto, California, USA
James Canfield, BS, Pulmonary Section, Veterans Affairs, Palo Alto Health Care System, Palo Alto, California, USA
Ware G. Kuschner, MD, Division of Pulmonary and Critical Care Medicine, Stanford University, Palo Alto, California, USA and Pulmonary Section, Veterans Affairs, Palo Alto Health Care System, Palo Alto, California, USA

Corresponding Author: Ware G. Kuschner, MD, U.S. Department of Veterans Affairs, Palo Alto Health Care System, 3801 Miranda Avenue, Mail Code: 111P, Palo Alto, CA, 94304, Tel: 650-493-5000, ext. 63544, Fax: 650-852-3276, Email: kuschner{at}stanford.edu

Objective: To determine the effect of inhaled corticosteroid (ICS) therapy on glucose control in adults with type 2 diabetes mellitus and coexisting asthma or chronic obstructive pulmonary disease (COPD).

Design: A prospective randomized, double-blind, double-dummy placebo-controlled, crossover investigation of inhaled steroids and oral leukotriene blockers.

Setting: A United States Department of Veterans Affairs Health Care System outpatient setting.

Participants: Adults with type 2 diabetes and asthma or COPD.

Methods: Subjects (n=12) were randomized to receive either inhaled fluticasone propionate (440 µg twice daily) and oral placebo, or inhaled placebo and oral montelukast (10 mg/day). After 6 weeks, subjects were switched to the opposite therapy for 6 weeks. The primary outcome measure was the change in the percentage of glycosylated hemoglobin (%HbA1c) at 6 weeks relative to the baseline value.

Results: Ten patients completed the study. The difference between the mean within-subject changes in %HbA1c associated with 6-week periods of fluticasone and the mean changes associated with montelukast therapy was small but statistically significant (mean difference=0.25; P<0.025). Neither fluticasone nor oral montelukast therapy for 6 weeks led to a significantly different mean % HbA1c compared with the relevant baseline (mean differences=0.11 and –0.14, respectively).

Conclusion: The absence of a clinically significant within-subject difference in the changes in %HbA1c associated with fluticasone versus oral montelukast therapy, or between either therapy or baseline does not warrant recommending changes in therapy for asthma or diabetes in patients with these co-morbid conditions. However, we suggest that clinicians carefully monitor blood glucose control when diabetic patients initiate ICS, especially with higher dosages.

Key Words: Asthma • COPD • Diabetes mellitus • Inhaled steroid

Disclosure: Merck & Co., USA provided funding support for the investigation. Merck played no role in the study design, in the collection, analysis, or interpretation of the data, or in the preparation of the manuscript. Merck did not review the final manuscript and provided no comments to the authors regarding the preparation of the manuscript. There were no confidentiality agreements with Merck regarding the study results. None of the investigators has any financial relationship to disclose.

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