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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Teneligliptin
Teneligliptin + Sulfonylurea
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring DPP-IV inhibitor

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reserch site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Teneligliptin

Teneligliptin + Sulfonylurea

Arm Description

Teneligliptin for 52 weeks

Teneligliptin for 52 weeks in combination with sulfonylurea

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
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

Change From Baseline in HbA1c at Week 52
Change From Baseline in Fasting Plasma Glucose at Week 52

Full Information

First Posted
December 8, 2014
Last Updated
July 29, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02314637
Brief Title
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
DPP-IV inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teneligliptin
Arm Type
Experimental
Arm Description
Teneligliptin for 52 weeks
Arm Title
Teneligliptin + Sulfonylurea
Arm Type
Experimental
Arm Description
Teneligliptin for 52 weeks in combination with sulfonylurea
Intervention Type
Drug
Intervention Name(s)
Teneligliptin
Intervention Description
Teneligliptin for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Teneligliptin + Sulfonylurea
Intervention Description
Teneligliptin for 52 weeks in combination with sulfonylurea
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 52
Time Frame
Baseline and Week 52
Title
Change From Baseline in Fasting Plasma Glucose at Week 52
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Kadowaki, Professor
Organizational Affiliation
Tokyo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Shikoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25861982
Citation
Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
Results Reference
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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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