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

February 24, 2008
April 12, 2013
January 2008
December 2008   (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.
Changes in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628212 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 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.
  • Blood glucose, Immuno Reactive Insulin (IRI), Glucagon, etc. [ 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
 
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
A Phase II, 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 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.

Not Provided
Interventional
Phase 2
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
  • Drug: Teneligliptin 10mg
    Other Name: MP-513
  • Drug: Teneligliptin 20 mg
    Other Name: MP-513
  • Drug: Teneligliptin 40 mg
    Other Name: MP-513
  • Drug: Placebo
  • Experimental: Teneligliptin 10 mg
    Teneligliptin 10 mg, orally, once daily
    Intervention: Drug: Teneligliptin 10mg
  • Experimental: Teneligliptin 20 mg
    Teneligliptin 20 mg, orally, once daily
    Intervention: Drug: Teneligliptin 20 mg
  • Experimental: Teneligliptin 40 mg
    Teneligliptin 40 mg, orally, once daily
    Intervention: Drug: Teneligliptin 40 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
324
January 2009
December 2008   (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 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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00628212
3000-A4
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
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
Mitsubishi Tanabe Pharma Corporation
April 2013

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