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

NCT00628212 | Completed Phase 2 Results

• 1 other identifier: 3000-A4
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Fasting Plasma Glucose at Week 12

  12 weeks

• Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12

  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

  12 weeks

Study Arms (4)

Teneligliptin 10 mg

EXPERIMENTAL

Teneligliptin 10 mg, orally, once daily

Drug: Teneligliptin 10mg

Teneligliptin 20 mg

EXPERIMENTAL

Teneligliptin 20 mg, orally, once daily

Drug: Teneligliptin 20 mg

Teneligliptin 40 mg

EXPERIMENTAL

Teneligliptin 40 mg, orally, once daily

Drug: Teneligliptin 40 mg

Placebo

PLACEBO COMPARATOR

Teneligliptin placebo-matching tablets, orally, once daily

Drug: Placebo

Interventions

Teneligliptin 10mg DRUG

Also known as: MP-513

Teneligliptin 10 mg

Teneligliptin 20 mg DRUG

Also known as: MP-513

Teneligliptin 20 mg

Teneligliptin 40 mg DRUG

Also known as: MP-513

Teneligliptin 40 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Takikawa-shi, Hokkaido, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Takashi Kadowaki, Professor, MD,PhD

  Tokyo University

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

• Tadashi Yoshida, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 4, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 2, 2026
• Results First Posted: May 31, 2013

Record last verified: 2025-12

Locations

JP (1)