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

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ClinicalTrials.gov Identifier: NCT01387737
Recruitment Status : Completed
First Posted : July 6, 2011
Results First Posted : April 28, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TA-7284-Low Drug: TA-7284-High Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus
Study Start Date : May 2011
Primary Completion Date : November 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: TA-7284-Low Drug: TA-7284-Low
TA-7284-Low
Experimental: TA-7284-High Drug: TA-7284-High
TA-7284-High



Primary Outcome Measures :
  1. Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events [ Time Frame: 54 weeks ]

Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 52 ]
  2. Change in Fasting Plasma Glucose [ Time Frame: Week 52 ]
  3. Change in Body Weight [ Time Frame: Week 52 ]
  4. Change in Blood Pressure [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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 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

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): NCT01387737


Locations
Japan
Research site
Chugoku, Japan
Research site
Hokkaido, Japan
Research site
Kanto, Japan
Research site
Kinki, Japan
Research site
Kyushu, Japan
Research site
Shikoku, Japan
Research site
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Nobuya Inagaki, M.D. Kyoto University, Graduate School of Medicine
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01387737     History of Changes
Other Study ID Numbers: TA-7284-06
First Posted: July 6, 2011    Key Record Dates
Results First Posted: April 28, 2014
Last Update Posted: June 6, 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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases