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NCT Number: NCT02354235

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Reserch site, Kanto, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

teneligliptin

Drug

Other names: Tenelia, MP-513

Canagliflozin

Drug

Other names: Canaglu, TA-7284

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, 24 Weeks

    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.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose Level

    Time frame: Baseline, 24 Weeks

    The change from baseline in fasting plasma glucose level collected at Week 24.

  2. Percentage Change in Body Weight From Baseline

    Time frame: Baseline, 24 Weeks

    The percentage change from baseline in body weight collected at Week 24.

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

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

    The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.

  4. Change From Baseline in 2-hour Postprandial Plasma Glucose Level

    Time frame: 2 Hours Postprandial, at Baseline and 24 Weeks

    The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2015
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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