Efficacy and 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:
NCT00628212
First received: February 24, 2008
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.


Condition Intervention Phase
Type 2 Diabetes
Drug: Teneligliptin 10mg
Drug: Teneligliptin 20 mg
Drug: Teneligliptin 40 mg
Drug: Placebo
Phase 2

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 II, 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 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.

  • 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.


Enrollment: 324
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teneligliptin 10 mg
Teneligliptin 10 mg, orally, once daily
Drug: Teneligliptin 10mg
Other Name: MP-513
Experimental: Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
Drug: Teneligliptin 20 mg
Other Name: MP-513
Experimental: Teneligliptin 40 mg
Teneligliptin 40 mg, orally, once daily
Drug: Teneligliptin 40 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 6.5 - 9.5%
  • Patients who were not administered 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 failure, 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.
  • 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: NCT00628212

Locations
Japan
Takikawa-shi, Hokkaidou, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Takashi Kadowaki, Professor, MD,PhD The University of Tokyo
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Study Director: Tadashi Yoshida, MD Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00628212     History of Changes
Other Study ID Numbers: 3000-A4
Study First Received: February 24, 2008
Results First Received: April 12, 2013
Last Updated: April 12, 2013
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 July 26, 2014