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Completed

NCT Number: NCT00971243

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are aged ≧ 18 years old.
  • Patients whose HbA1c is ≧ 7.0 % and < 10.0%.
  • Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
  • Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion criteria

  • Patients with type 1 diabetes or secondary form of diabetes.
  • Patients with heart failure symptoms.
  • Patients with serious diabetic complications.
  • Patients with severe hepatic disorder or severe renal disorder.
  • Patients who are the excessive alcohol addicts.
  • Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.

Treatment and study plan

MP-513 Lowest Dose and Metformin

Drug

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 Metformin

Drug

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 Metformin

Drug

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 Metformin

Drug

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

Placebo and Metformin

Drug

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

Primary outcomes

  1. Change in HbA1c From Baseline to Week 24

    Time frame: Baseline and Week 24

    The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.

Secondary outcomes

  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

    Time frame: Baseline and Week 24

    Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

  2. Adverse Events, Laboratory Tests, Vital Signs, Etc.

    Time frame: Weeks 24, 52

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2009
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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