NCT04100473

Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dance Biopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

Detailed description

To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Inhaled Human Insulin	Dance 501 administered using the Dance 501 Inhaler
DRUG	Insulin Lispro (Humalog U-100)	Lispro

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-08-11
• Completion: 2019-08-01
• First posted: 2019-09-24
• Last updated: 2019-09-24

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study