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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01301833
First received: February 14, 2011
Last updated: July 31, 2015
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Teneli
Drug: Teneli + Glin
Drug: Teneli + BG
Drug: Teneli + A-GI
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose at Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Glucagon at Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 462
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teneli
Teneligliptin
Drug: Teneli
Other Name: MP-513
Experimental: Teneli + Glin
Teneligliptin plus glinide
Drug: Teneli + Glin
Experimental: Teneli + BG
Teneligliptin plus biguanide
Drug: Teneli + BG
Experimental: Teneli + A-GI
Teneligliptin plus alpha-glucosidase inhibitor
Drug: Teneli + A-GI

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301833

Locations
Japan
Chitose-shi, Hokkaidou, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Takashi Kadowaki, Professor Tokyo University
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
  More Information

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01301833     History of Changes
Other Study ID Numbers: 3000-A14
Study First Received: February 14, 2011
Results First Received: July 31, 2015
Last Updated: July 31, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 31, 2015