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

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Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus

NCT01301833•Tanabe Pharma Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
•Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
•Patients whose HbA1c is between 6.5% - 10.0%
•Patients who were not administered diabetes therapeutic 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 impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
•Patients who are accepting treatments of arrhythmias
•Patients with serious diabetic complications
•Patients who are habitual excessive alcohol consumption.
•Patients with severe hepatic disorder or severe renal disorder.
•Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Locations (1)

Chitose-shi, Hokkaido, Japan

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

January 2, 2026

Enrollment

462

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

teneligliptin

DRUG

glinide

DRUG

biguanide

DRUG

alpha-glucosidase inhibitor

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

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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Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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