drugset / Trial / NCT00469586

Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

NCT00469586

Phase 3 Terminated 174 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Timeline

Start
2007-04-26
Primary completion
2008-04-24
Completion
2008-04-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 4 mg Oral
Subject Insulin Protein / enzyme biologic Inhaled
Comparator Metformin Small molecule 2000 mg Oral