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

NCT00971243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2026-01-07

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • David Kerr, Dr · Royal Bournemouth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Denmark
  • Germany
  • Hungary
  • Lithuania
  • Poland
  • Romania
  • United Kingdom

Study Locations

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Entities

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 NCT00971243 on ClinicalTrials.gov