NCT00971243

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

A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	MP-513 Lowest Dose and Metformin	MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUG	MP-513 Low Dose and Metformin	MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUG	MP-513 Medium Dose and Metformin	MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUG	MP-513 High Dose and Metformin	MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUG	Placebo and Metformin	Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-09-03
• Last updated: 2026-01-07
• Results posted: 2014-09-01

Locations

44 sites across 7 countries: Denmark, Germany, Hungary, Lithuania, Poland, Romania, United Kingdom