Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
First received: August 4, 2011
Last updated: September 19, 2012
Last verified: September 2012

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: TA-7284 Low
Drug: TA-7284 High
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting plasma glucose [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in Blood pressure [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in postprandial plasma glucose, insulin and urinary glucose excretion after a 75g oral glucose tolerance test [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by adverse events, hypoglycemic events, laboratory tests, 12-lead ECG and vital signs [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 272
Study Start Date: July 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-7284 Low Drug: TA-7284 Low
The patients will receive TA-7284-Low orally for 24 weeks.
Experimental: TA-7284 High Drug: TA-7284 High
The patients will receive TA-7284-High orally for 24 weeks.
Placebo Comparator: Placebo Drug: Placebo
The patients will receive Placebo orally for 24 weeks.

Detailed Description:

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women age ≥20 years old
  • Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
  • HbA1c of ≥7.0% and ≤10.0%

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 > 270mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413204

Reserch site
Chubu, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Reserch site
Shikoku, Japan
Reserch site
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Director: Nobuya Inagaki, M.D. Kyoto University, Graduate School of Medicine
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01413204     History of Changes
Other Study ID Numbers: TA-7284-05
Study First Received: August 4, 2011
Last Updated: September 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Sodium Glucose Co-transporter (SGLT2 inhibitor)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014