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Completed

NCT Number: NCT02220907

Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site, Chugoku, 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 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

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/Canagliflozin

Drug

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

Other names: Tenelia, MP-513, Canaglu, TA-7284

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 52 Weeks

Secondary outcomes

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

    Time frame: Baseline, 52 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 52.

  2. Change From Baseline in Fasting Plasma Glucose Level

    Time frame: Baseline, 52 Weeks

    The change from baseline in fasting plasma glucose level collected at Week 52.

  3. Percentage Change in Body Weight From Baseline

    Time frame: Baseline, 52 Weeks

    The percentage change from baseline in body weight collected at Week 52.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2014
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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