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Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02314637
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : January 2, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date : August 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Teneligliptin
Teneligliptin for 52 weeks
Drug: Teneligliptin
Teneligliptin for 52 weeks

Experimental: Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea
Drug: Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 52 weeks ]
    Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ]
  2. Change From Baseline in Fasting Plasma Glucose at Week 52 [ Time Frame: Baseline and Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug
  • Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
  • HbA1c criteria:

    • monotherapy: 6.9% - 10.5%
    • combination therapy with Sulfonylurea: 7.4 - 10.5%
  • Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

  • Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
  • Patients who are accepting treatments of arrhythmias
  • Patients with serious diabetic complications
  • Patients who are the excessive alcohol addicts
  • Patients with severe hepatic disorder or severe renal disorder
  • Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

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): NCT02314637


Locations
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Japan
Reserch site
Shikoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Takashi Kadowaki, Professor Tokyo University
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation

Publications of Results:
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02314637     History of Changes
Other Study ID Numbers: 3000-A8
First Posted: December 11, 2014    Key Record Dates
Results First Posted: January 2, 2015
Last Update Posted: August 20, 2015
Last Verified: July 2015
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
DPP-IV inhibitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases