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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: Metformin ≥ 1000 mg

Drug: Teneligliptin 20mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02924064

MP-513-C03

Details and patient eligibility

About

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) in combination with metformin.

Enrollment

247 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A signed and dated informed consent form obtained from the subject, in accordance.
The subject is aged ≥18 years at signature of the informed consent form.
Hospitalization status: outpatient.
The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin 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 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).