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Use of Inhaled Insulin in a Basal/Bolus Insulin Regimen in Type 1 Diabetic Subjects

A 6-month, randomized, comparative trial

¹ University of Miami School of Medicine, Miami, Florida
² Joslin Diabetes Center, State University of New York Upstate Medical University, Syracuse, New York
³ Veterans Affairs Medical Center, Syracuse, New York
⁴ University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
⁵ McGill Nutrition and Food Science Centre, Royal Victoria Hospital, Montreal, Canada
⁶ University of Virginia School of Medicine, Charlottesville, Virginia
⁷ University of Rochester School of Medicine, Rochester, New York
⁸ Division of Endocrinology and Metabolism, McMaster University, Ontario, Canada

Address correspondencereprint requests to Jay S. Skyler, MD, University of Miami, 1450 NW 10th Ave., Suite 3054, Miami, FL 33136. E-mail: jskyler{at}miami.edu

OBJECTIVE—Despite the demonstrated benefits of glycemic control, patient acceptance of basal/bolus insulin therapy for type 1 diabetes has been slow. We investigated whether a basal/bolus insulin regimen involving rapid-acting, dry powder, inhaled insulin could provide glycemic control comparable with a basal/bolus subcutaneous regimen.

RESEARCH DESIGN AND METHODS—Patients with type 1 diabetes (ages 12–65 years) received twice-daily subcutaneous NPH insulin and were randomized to premeal inhaled insulin (n = 163) or subcutaneous regular insulin (n = 165) for 6 months.

RESULTS—Mean glycosylated hemoglobin (A1C) decreased comparably from baseline in the inhaled and subcutaneous insulin groups (–0.3 and –0.1%, respectively; adjusted difference –0.16% [CI –0.34 to 0.01]), with a similar percentage of subjects achieving A1C <7%. Although 2-h postprandial glucose reductions were comparable between the groups, fasting plasma glucose levels declined more in the inhaled than in the subcutaneous insulin group (adjusted difference –39.5 mg/dl [CI –57.5 to –21.6]). Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. The overall hypoglycemia rate (episodes/patient-month) was 9.3 (inhaled) vs. 9.9 (subcutaneous) (risk ratio [RR] 0.94 [CI 0.91–0.97]), and the severe hypoglycemia rate (episodes/100 patient-months) was 6.5 vs. 3.3 (RR 2.00 [CI 1.28–3.12]). Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxide–diffusing capacity in the inhaled insulin group without any clinical correlates.

CONCLUSIONS—Inhaled insulin may provide an alternative for the management of type 1 diabetes as part of a basal/bolus strategy in patients who are unwilling or unable to use preprandial insulin injections.

Abbreviations: FPG, fasting plasma glucose • IAb, insulin antibody • SMBG, self-monitoring of blood glucose

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