CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 448 enrolled
Drug / intervention
MP-513 Lowest Dose and Metformin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00971243
NCT00971243Phase 2Completed
CompareCT.gov

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

Tanabe Pharma Corporation·interventional·Posted Sep 3, 2009·Updated Jan 7, 2026

In Brief

A Phase 2 clinical trial evaluating MP-513 Lowest Dose and Metformin, MP-513 Low Dose and Metformin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 448 participants across 44 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesDenmark, Germany, Hungary, Lithuania, Poland, Romania, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.8 years ago

Interventions

MP-513 Lowest Dose and Metformindrug

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

MP-513 Low Dose and Metformindrug

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

MP-513 Medium Dose and Metformindrug

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

MP-513 High Dose and Metformindrug

MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Placebo and Metformindrug

Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.