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

NCT00628212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-01-02

Study results available
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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.

Conditions

Interventions

DRUG

Teneligliptin 10mg

DRUG

Teneligliptin 20 mg

DRUG

Teneligliptin 40 mg

DRUG

Placebo

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Takashi Kadowaki, Professor, MD,PhD · Tokyo University

  • Kazuoki Kondo, MD · Tanabe Pharma Corporation

  • Tadashi Yoshida, MD · Tanabe Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Japan

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00628212 on ClinicalTrials.gov