drugset / Trial / NCT00628212

Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

NCT00628212

Phase 2 Completed 324 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Timeline

Start
2008-01
Primary completion
2008-12
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Teneligliptin Small molecule 10 mg Oral
Subject Teneligliptin Small molecule 20 mg Oral
Subject Teneligliptin Small molecule 40 mg Oral