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-

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: Teneligliptin 10mg; Drug: Teneligliptin 20 mg; Drug: Teneligliptin 40 mg

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Takikawa-shi, Hokkaido, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teneligliptin 20 mg; Teneligliptin 20 mg, orally, once daily	Drug: Teneligliptin 20 mg; Other Names: MP-513
Placebo Comparator: Placebo; Teneligliptin placebo-matching tablets, orally, once daily	Drug: Placebo
Experimental: Teneligliptin 10 mg; Teneligliptin 10 mg, orally, once daily	Drug: Teneligliptin 10mg; Other Names: MP-513
Experimental: Teneligliptin 40 mg; Teneligliptin 40 mg, orally, once daily	Drug: Teneligliptin 40 mg; Other Names: MP-513

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c at Week 12	The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Plasma Glucose at Week 12	The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.	12 weeks
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12	The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.	12 weeks
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12	The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.	12 weeks

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Study Director: Takashi Kadowaki, Professor, MD,PhD, Tokyo University; Study Director: Kazuoki Kondo, MD, Tanabe Pharma Corporation; Study Director: Tadashi Yoshida, MD, Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: February 24, 2008
• First Submitted That Met QC Criteria: February 24, 2008
• First Posted (Estimated): March 4, 2008

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: insulin resistance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance; 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
• Other Study ID Numbers: 3000-A4