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An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01022112
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

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

Detailed Description:
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally-Administered SGLT2 Inhibitor TA-7284
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


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

Experimental: TA-7284-Low-middle Drug: TA-7284-Low-middle
TA-7284-Low-middle

Experimental: TA-7284-High-middle Drug: TA-7284-High-middle
TA-7284-High-middle

Experimental: TA-7284-High Drug: TA-7284-High
TA-7284-High

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Fasting Blood Glucose, Body Weight [ Time Frame: 12 weeks ]
  2. Safety and Tolerability [ Time Frame: 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged from 20 to 80 years inclusive on the day of informed consent;
  • Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
  • Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society [JDS] criteria) on the start day of the run-in period;

Exclusion Criteria:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
  • Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
  • Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;
  • eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;
  • Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
  • History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
  • Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
  • Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
  • Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
  • Pregnant women, lactating mothers, or women of childbearing potential;
  • Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

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): NCT01022112


Locations
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Japan
Research site
Chugoku, 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
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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
Study Director: Tadashi Yoshida, M.D. Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01022112     History of Changes
Other Study ID Numbers: TA-7284-04
First Posted: December 1, 2009    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
Type 2 diabetes mellitus
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
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs