Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dance Biopharm Inc.
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus treated with multiple daily insulin injections or continuous subcutaneous insulin infusion and total daily insulin dose less than 1.2 units/kg/day.

• Body mass index 18.0 - 28.0 kg/m2.

• Hemoglobin A1c less than or equal to 9%.

• Forced vital capacity and forced expiratory volume in one second at least 75% of predicted normal values for race, age, gender and height.

• Fasting C-peptide less than 0.3 nmol/L.

Exclusion Criteria:

• Subjects with any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.

• Active or chronic pulmonary disease.

• Any clinically significant major disorders other than diabetes mellitus.

• Decompensated heart failure at any time or angina pectoris within the last 12 months or acute myocardial infarction at any time.

• Proliferative retinopathy or severe neuropathy.