drugset / Trial / NCT00069836

Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.

NCT00069836 ↗

Phase 3 Completed 272 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

Timeline

Start
2003-10
Primary completion
2004-11
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosiglitazone/metformin Unknown 8 mg —
Subject Rosiglitazone/metformin Unknown 2 g —