NCT01196104

Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Detailed description

Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin Inhalation Powder
DRUG	Insulin Aspart	Usual Care
DRUG	Insulin Glargine

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2012-03-01
• First posted: 2010-09-08
• Last updated: 2014-10-30
• Results posted: 2014-10-21

Locations

29 sites across 1 country: United States