Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

October 15, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaidou
      • Chitose-shi, Hokkaidou, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) 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
  • Patients whose HbA1c is between 6.5% - 10.0%
  • 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 habitual excessive alcohol consumption.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teneligliptin
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Drug: teneligliptin
Other Names:
  • MP-513
Experimental: teneligliptin and glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Drug: teneligliptin
Other Names:
  • MP-513
Drug: glinide
Experimental: teneligliptin and biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Drug: teneligliptin
Other Names:
  • MP-513
Drug: biguanide
Experimental: teneligliptin and alpha-glucosidase inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Drug: teneligliptin
Other Names:
  • MP-513
Drug: alpha-glucosidase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in HbA1c at Week 52
Time Frame: Baseline and 52 weeks
Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose at Week 52
Time Frame: Baseline and 52 weeks
Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52
Time Frame: Baseline and 52 weeks
Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time Frame: Baseline and 52 weeks
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 21, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3000-A14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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