Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01387737
First received: June 28, 2011
Last updated: May 27, 2014
Last verified: May 2014

June 28, 2011
May 27, 2014
May 2011
November 2012   (final data collection date for primary outcome measure)
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability assessed by adverse events, hypoglycemic events, laboratory tests, 12-lead ECG and vital signs [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01387737 on ClinicalTrials.gov Archive Site
  • Change in HbA1c [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in Blood Pressure [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: TA-7284-Low
    TA-7284-Low
  • Drug: TA-7284-High
    TA-7284-High
  • Experimental: TA-7284-Low
    Intervention: Drug: TA-7284-Low
  • Experimental: TA-7284-High
    Intervention: Drug: TA-7284-High
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1299
December 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women age ≥20 years old
  • Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
  • HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
  • HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Exclusion Criteria:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
  • Past or current history of severe diabetic complications
  • Fasting plasma glucose > 270 mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01387737
TA-7284-06
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Director: Nobuya Inagaki, M.D. Kyoto University, Graduate School of Medicine
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
May 2014

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