NCT02314637

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2009

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
22 days until next milestone

Results Posted

Study results publicly available

January 2, 2015

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 8, 2014

Results QC Date

December 12, 2014

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

DPP-IV inhibitor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.

    52 weeks

Secondary Outcomes (2)

  • Change From Baseline in HbA1c at Week 52

    Baseline and Week 52

  • Change From Baseline in Fasting Plasma Glucose at Week 52

    Baseline and Week 52

Study Arms (2)

Teneligliptin

EXPERIMENTAL

Teneligliptin for 52 weeks

Drug: Teneligliptin

Teneligliptin + Sulfonylurea

EXPERIMENTAL

Teneligliptin for 52 weeks in combination with sulfonylurea

Drug: Teneligliptin + Sulfonylurea

Interventions

TeneligliptinDRUG

Teneligliptin for 52 weeks

Teneligliptin
Teneligliptin + SulfonylureaDRUG

Teneligliptin for 52 weeks in combination with sulfonylurea

Teneligliptin + Sulfonylurea

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea 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
  • HbA1c criteria:
  • monotherapy: 6.9% - 10.5%
  • combination therapy with Sulfonylurea: 7.4 - 10.5%
  • Patients who were not administered diabetes therapeutic 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 impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
  • Patients who are accepting treatments of arrhythmias
  • Patients with serious diabetic complications
  • Patients who are the excessive alcohol addicts
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reserch site

Shikoku, Japan

Location

Related Publications (1)

  • Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.

    PMID: 25861982RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

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

    Tokyo University

    STUDY DIRECTOR

  • Kazuoki Kondo, 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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 11, 2014

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 5, 2026

Results First Posted

January 2, 2015

Record last verified: 2025-12

Locations

JP(1)