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Long-term 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:
NCT01301833
First received: February 14, 2011
Last updated: October 15, 2015
Last verified: October 2015

February 14, 2011
October 15, 2015
February 2011
September 2012   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Number of Participants With Adverse Events [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01301833 on ClinicalTrials.gov Archive Site
  • Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Glucagon at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Blood glucose [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Glucagon [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Immuno Reactive Insulin (IRI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: teneligliptin
    Other Name: MP-513
  • Drug: glinide
  • Drug: biguanide
  • Drug: alpha-glucosidase inhibitor
  • Experimental: teneligliptin
    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
    Intervention: Drug: teneligliptin
  • Experimental: teneligliptin and glinide
    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
    Interventions:
    • Drug: teneligliptin
    • Drug: glinide
  • Experimental: teneligliptin and biguanide
    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
    Interventions:
    • Drug: teneligliptin
    • Drug: biguanide
  • Experimental: teneligliptin and alpha-glucosidase inhibitor
    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Interventions:
    • Drug: teneligliptin
    • Drug: alpha-glucosidase inhibitor
Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
462
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
  • 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 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 who are accepting treatments of arrhythmias
  • 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 and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01301833
3000-A14
No
Not Provided
Not Provided
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
October 2015

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