Monotherapy 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:
NCT00998881
First received: October 15, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Teneligliptin 20 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Placebo Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus - Confirmative Study

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change From Baseline in HbA1c at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.

  • Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.

  • Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.


Enrollment: 203
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
Drug: Teneligliptin 20 mg
Other Name: MP-513
Placebo Comparator: Placebo
Teneligliptin placebo-matching tablets, orally, once daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are 20 - 75 years old
  • 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 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 with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998881

Locations
Japan
Sapporo-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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00998881     History of Changes
Other Study ID Numbers: 3000-A5
Study First Received: October 15, 2009
Results First Received: January 8, 2014
Last Updated: January 8, 2014
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014