NCT00332488

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Technosphere Insulin	Inhalation, 15U/30U, prandial
DRUG	Metformin & Secretagogues	Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
DRUG	Technosphere Insulin & Metformin	Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-03-01
• First posted: 2006-06-01
• Last updated: 2014-10-16
• Results posted: 2014-10-16

Locations

120 sites across 11 countries: United States, Argentina, Brazil, Canada, Chile, Czechia, Mexico, Poland, Russia, Spain, Ukraine