Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus

NCT02916706•Tanabe Pharma Corporation

Summary

This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
•The subject is aged ≥18 years at signature of the informed consent form.
•Hospitalization status: outpatient.
•The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
•The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
•The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria

•The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
•The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
•The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

Locations (1)

Investigational center

Beijing, China

Key Dates

Start Date

September 1, 2016

Primary Completion Date

August 14, 2018

Last Updated

January 6, 2026

Enrollment

254

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Teneligliptin 20mg

DRUG

Placebo

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 6, 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.

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Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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