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Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00974090
First received: September 8, 2009
Last updated: April 7, 2014
Last verified: April 2014

September 8, 2009
April 7, 2014
September 2009
March 2011   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c at Week 12 [ Time Frame: at Week 0 and Week 12 ] [ 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: Weeks 12, 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00974090 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: at Week 0 and Week 12 ] [ 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: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 ] [ 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: at Week 0 and Week 12 ] [ 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.
  • Blood glucose, Immuno Reactive Insulin (IRI), Glucagon, etc. [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests, physical data, etc. [ Time Frame: Weeks 12, 52 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
A Phase III Study of MP-513 in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

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: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)
    Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
    Other Names:
    • MP-513
    • Amaryl
    • glimepiride
  • Drug: Teneli / Teneli + SU
    Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
    Other Names:
    • MP-513
    • Amaryl
    • glimepiride
  • Placebo Comparator: Placebo / Teneli + SU
    Intervention: Drug: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)
  • Experimental: Teneli / Teneli + SU
    Intervention: Drug: Teneli / Teneli + SU
Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
March 2011
March 2011   (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 7.0% and 10.0%
  • Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
  • 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 with Class III/IV heart failure symptoms according to NYHA functional classification
  • Patients who are gastrointestinal disorder (diarrhea, vomiting)
  • Patients with serious diabetic complications
  • Patients who are the excessive alcohol addicts
  • 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
 
NCT00974090
3000-A6
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
April 2014

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