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: August 6, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1299
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-7284-Low Drug: TA-7284-Low
TA-7284-Low
Experimental: TA-7284-High Drug: TA-7284-High
TA-7284-High

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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 > 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: 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
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01387737     History of Changes
Other Study ID Numbers: TA-7284-06
Study First Received: June 28, 2011
Last Updated: August 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 17, 2014