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

May 27, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
        • Reserch site
      • Kanto, Japan
        • Reserch site
      • Kinki, Japan
        • Reserch site
      • Shikoku, Japan
        • Reserch site
      • Tohoku, Japan
        • Reserch site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
The patients will receive Placebo orally for 24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Time Frame: baseline and 24 weeks
baseline and 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-7284-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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