drugset / Trial / 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

NCT00332488

Phase 3 Completed 547 enrolled Mannkind Corporation
RandomizedCrossoverOpen-labelTreatment

Summary

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

Timeline

Start
2004-12
Primary completion
2008-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 15 iu Inhaled
Subject Insulin Protein / enzyme biologic 30 iu Inhaled
Comparator Metformin Small molecule Oral