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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 Identifier:
First received: August 4, 2011
Last updated: May 27, 2014
Last verified: May 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) [ Time Frame: baseline and 24 weeks ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose [ Time Frame: Week 24 ]
  • Change in Body Weight [ Time Frame: Week 24 ]
  • Change in Blood Pressure [ Time Frame: Week 24 ]
  • Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test [ Time Frame: Week 24 ]
  • Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs [ Time Frame: Week 24 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 > 270 mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01413204     History of Changes
Other Study ID Numbers: TA-7284-05
Study First Received: August 4, 2011
Results First Received: March 26, 2014
Last Updated: May 27, 2014

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 processed this record on June 23, 2017