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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01413204
Recruitment Status : Completed
First Posted : August 10, 2011
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TA-7284 Low Drug: TA-7284 High Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : July 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413204


Locations
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Japan
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
Investigators
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Study Director: Nobuya Inagaki, M.D. Kyoto University, Graduate School of Medicine
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01413204    
Other Study ID Numbers: TA-7284-05
First Posted: August 10, 2011    Key Record Dates
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: May 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
TA-7284
JNJ-28431754
Canagliflozin
Sodium Glucose Co-transporter (SGLT2 inhibitor)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases