NCT02713841

Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

Samba-01: A Phase 1/2 Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dance Biopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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, MOM was used twice. Pharmacokinetics (PK) were measured up to 8 hours after dosing.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	inhaled human insulin (INH)	recombinant human insulin administered with Adagio-01 inhaler device
DRUG	sc insulin lispro (LIS)	insulin lispro administered subcutaneously

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2016-03-21
• Last updated: 2016-03-21