Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

Launched by DANCE BIOPHARM INC. · Mar 15, 2016

Keywords

ClinConnect Summary

This first-in-human trial investigated the optimal particle size for absorption of Dance-501, an aerosolized liquid human insulin for inhalation (INH).

Twelve subjects with type 1 diabetes received an INH dose (50 IU) using an inhaler on 4 visits and 6 U insulin lispro (LIS) sc on a separate visit to assess relative bioavailability (FREL) of INH. The inhaler was configured to generate insulin aerosol particles sized 3.5-4.0 μm (low output mesh; LOM), 4.3-4.8 μm (medium output mesh; MOM) or 5.0-5.5 μm (high output mesh; HOM) during low inspiratory flow. To assess within subject variability,...

Gender

ALL

Eligibility 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.