NCT00700622

Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Conditions

• Diabetes, Type 1

Interventions

Type	Name	Description
DRUG	Technosphere Insulin	Technosphere Insulin Inhalation Powder 15U or 30U
DRUG	Insulin glargine	Lantus-injectible supplied as 3mL (300 units) pens
DRUG	Insulin lispro	Humalog autopen cartridges pre-filled with 3mL (300 units)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-11-01
• Completion: 2010-03-01
• First posted: 2008-06-18
• Last updated: 2014-10-16
• Results posted: 2014-10-16

Locations

22 sites across 2 countries: United States, Brazil