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

NCT02354235 | Completed Phase 3 Results

• 1 other identifier: MT-2412-J03
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 3

Brief Summary

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

Canagliflozin + Teneligliptin

EXPERIMENTAL

Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.

Drug: Teneligliptin; Drug: Canagliflozin

Placebo + Teneligliptin

PLACEBO COMPARATOR

Patients receive placebo for 24 weeks in combination with Teneligliptin.

Drug: Teneligliptin; Drug: Placebo

Interventions

Teneligliptin DRUG

Also known as: Tenelia, MP-513

Canagliflozin + Teneligliptin; Placebo + Teneligliptin

Canagliflozin DRUG

Also known as: Canaglu, TA-7284

Canagliflozin + Teneligliptin

Placebo DRUG

Placebo + Teneligliptin

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, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.

  PMID: 28177187 RESULT

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)thiazolidine; Canagliflozin

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, MD

  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: 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: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 7, 2026
• Results First Posted: August 16, 2018

Record last verified: 2025-12

Locations

JP (3)