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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

October 15, 2009
January 8, 2014
September 2009
June 2010   (final data collection date for primary outcome measure)
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.
Change in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00998881 on ClinicalTrials.gov Archive Site
  • 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.
  • Change from baseline in Blood glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Immuno Reactive Insulin (IRI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glucagon [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests, vital signs, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
A Phase III, Double-blind, Placebo Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus - Confirmative Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Teneligliptin 20 mg
    Other Name: MP-513
  • Drug: Placebo
  • Experimental: Teneligliptin 20 mg
    Teneligliptin 20 mg, orally, once daily
    Intervention: Drug: Teneligliptin 20 mg
  • Placebo Comparator: Placebo
    Teneligliptin placebo-matching tablets, orally, once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00998881
3000-A5
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Director: Takashi Kadowaki, Professor Tokyo University
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP