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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220907
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : August 16, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Teneligliptin/Canagliflozin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus
Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Teneligliptin/Canagliflozin
Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
 Drug: Teneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Other Names:
  • Tenelia
  • MP-513
  • Canaglu
  • TA-7284


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220907


Locations
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Japan
Research site
Chubu, Japan
Research site
Chugoku, Japan
Research site
Hokkaido, Japan
Research site
Kanto, Japan
Research site
Kyushu, Japan
Research site
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Takashi Kadowaki, MD Tokyo University
Study Director: Nobuya Inagaki, MD Kyoto University
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
More Information
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Publications of Results:

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02220907    
Other Study ID Numbers: MT-2412-J01
First Posted: August 20, 2014    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: November 1, 2018
Last Verified: October 2018
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
MT-2412
MP-513
TA-7284
Teneligliptin
Canagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs