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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

TA-7284 Low

TA-7284 High

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-transporter (SGLT2 inhibitor)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Reserch site
Reserch site
Reserch site
Reserch site
Reserch site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TA-7284 Low

TA-7284 High

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)

Secondary Outcome Measures

Change in Fasting Plasma Glucose

Change in Body Weight

Change in Blood Pressure

Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs

Full Information

NCT ID

NCT01413204

First Posted

August 4, 2011

Last Updated

May 27, 2014

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01413204

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-transporter (SGLT2 inhibitor)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

272 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TA-7284 Low

Arm Type

Experimental

Arm Title

TA-7284 High

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TA-7284 Low

Intervention Description

The patients will receive TA-7284-Low orally for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

TA-7284 High

Intervention Description

The patients will receive TA-7284-High orally for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The patients will receive Placebo orally for 24 weeks.

Primary Outcome Measure Information:

Title

Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)

Time Frame

baseline and 24 weeks

Secondary Outcome Measure Information:

Title

Change in Fasting Plasma Glucose

Time Frame

Week 24

Title

Change in Body Weight

Time Frame

Week 24

Title

Change in Blood Pressure

Time Frame

Week 24

Title

Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test

Time Frame

Week 24

Title

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nobuya Inagaki, M.D.

Organizational Affiliation

Kyoto University, Graduate School of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Kazuoki Kondo, M.D.

Organizational Affiliation

Mitsubishi Tanabe Pharma Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Reserch site

City

Chubu

Country

Japan

Facility Name

Reserch site

City

Kanto

Country

Japan

Facility Name

Reserch site

City

Kinki

Country

Japan

Facility Name

Reserch site

City

Shikoku

Country

Japan

Facility Name

Reserch site

City

Tohoku

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25010793

Citation

Inagaki N, Kondo K, Yoshinari T, Takahashi N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study. Expert Opin Pharmacother. 2014 Aug;15(11):1501-15. doi: 10.1517/14656566.2014.935764.

Results Reference

derived

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

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