drugset / Trial / NCT01453049

An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients

NCT01453049

Phase 3 Terminated 86 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).

Timeline

Start
2010-04
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 1 mg Oral
Comparator Glimepiride Small molecule 2 mg Oral
Comparator Glimepiride Small molecule 4 mg Oral
Subject Rosiglitazone Small molecule 4 mg Oral