Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

NCT02354222 | Completed Phase 3 Results

• 1 other identifier: MT-2412-J02
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Conditions

Type 2 Diabetes Mellitus

Keywords

MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin

Outcome Measures

Primary Outcomes (1)

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

  The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.

  Baseline, 24 Weeks

Secondary Outcomes (4)

• Change From Baseline in Fasting Plasma Glucose Level

  Baseline, 24 Weeks

• Percentage Change in Body Weight From Baseline

  Baseline, 24 Weeks

• Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)

  0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks

• Change From Baseline in 2-hour Postprandial Plasma Glucose Level

  2 Hours Postprandial, at Baseline and 24 Weeks

Study Arms (2)

Teneligliptin + Canagliflozin

EXPERIMENTAL

Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin.

Drug: Canagliflozin; Drug: Teneligliptin

Placebo + Canagliflozin

PLACEBO COMPARATOR

Patients receive placebo for 24 weeks in combination with Canagliflozin.

Drug: Canagliflozin; Drug: Placebo

Interventions

Canagliflozin DRUG

Also known as: Canaglu, TA-7284

Placebo + Canagliflozin; Teneligliptin + Canagliflozin

Teneligliptin DRUG

Also known as: Tenelia, MP-513

Teneligliptin + Canagliflozin

Placebo DRUG

Placebo + Canagliflozin

Eligibility Criteria

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

You may qualify if:

• Men or women who are 20 - 75 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 8 weeks before run-in 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (3)

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Reserch site

Tōhoku, Japan

Location

Related Publications (1)

• Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Gouda M, Iijima H, Watanabe Y. Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study. Diabetes Obes Metab. 2018 Feb;20(2):453-457. doi: 10.1111/dom.13079. Epub 2017 Sep 15.

  PMID: 28786530 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; 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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

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, M.D.

  Tokyo University

  STUDY DIRECTOR

• Kazuoki Kondo, M.D.

  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: 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: January 29, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• 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 (3)