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Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase II, Double-Blind, Placebo-Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus -Confirmative Study-

NCT00628212•Tanabe Pharma Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who are 20 - 75 years old
•Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
•Patients whose HbA1c is 6.5 - 9.5%
•Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria

•Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
•Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
•Patients with serious diabetic complications
•Patients who are habitual excessive alcohol consumption.
•Patients with severe hepatic disorder or severe renal disorder.
•Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Locations (1)

Takikawa-shi, Hokkaido, Japan

Key Dates

Start Date

January 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

January 1, 2009

Last Updated

January 2, 2026

Enrollment

324

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Teneligliptin 10mg

DRUG

Teneligliptin 20 mg

DRUG

Teneligliptin 40 mg

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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