drugset / Trial / NCT00348712

Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

NCT00348712

Phase 3 Terminated 301 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Timeline

Start
2006-10-30
Primary completion
2008-03-05
Completion
2008-03-05

Drugs

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