NCT02716610

Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dance Biopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

Detailed description

This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS). The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INH 69 U (low)	inhaled human insulin
DRUG	INH 69 U (high)	inhaled human insulin
DRUG	INH 139 U	inhaled human insulin
DRUG	INH 208 U	inhaled human insulin
DRUG	LIS 18 U	subcutaneous insulin lispro

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2016-03-23
• Last updated: 2016-03-23