NCT02220907

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

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

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

6 active sites

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, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

August 19, 2014

Results QC Date

November 16, 2017

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

MT-2412MP-513TA-7284TeneligliptinCanagliflozin

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    52 Weeks

Secondary Outcomes (3)

  • Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

    Baseline, 52 Weeks

  • Change From Baseline in Fasting Plasma Glucose Level

    Baseline, 52 Weeks

  • Percentage Change in Body Weight From Baseline

    Baseline, 52 Weeks

Study Arms (1)

Teneligliptin/Canagliflozin

EXPERIMENTAL

Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.

Drug: Teneligliptin/Canagliflozin

Interventions

Teneligliptin/CanagliflozinDRUG

Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.

Also known as: Tenelia, MP-513, Canaglu, TA-7284
Teneligliptin/Canagliflozin

Eligibility Criteria

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

You may qualify if:

  • Men or women age ≥20 years old
  • HbA1c of ≥7.0% and \<10.5%
  • FPG of ≤ 270 mg/dL
  • Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

You may not qualify if:

  • Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
  • Patients with serious diabetic complications
  • Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
  • Patients with severe hepatic disorder or severe renal disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research site

Chugoku, Japan

Location

Research site

Chūbu, Japan

Location

Research site

Hokkaido, Japan

Location

Research site

Kanto, Japan

Location

Research site

Kyushu, Japan

Location

Research site

Tōhoku, Japan

Location

Related Publications (1)

  • Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.

    PMID: 28608617RESULT

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)thiazolidineCanagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

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, MD

    Tokyo University

    STUDY DIRECTOR

  • Nobuya Inagaki, MD

    Kyoto 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 7, 2026

Results First Posted

August 16, 2018

Record last verified: 2025-12

Locations

JP(6)