NCT01413204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 5, 2014

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

August 4, 2011

Results QC Date

March 26, 2014

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

TA-7284JNJ-28431754CanagliflozinSodium Glucose Co-transporter (SGLT2 inhibitor)

Outcome Measures

Primary Outcomes (1)

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

    baseline and 24 weeks

Secondary Outcomes (5)

  • Change in Fasting Plasma Glucose

    Week 24

  • Change in Body Weight

    Week 24

  • Change in Blood Pressure

    Week 24

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

    Week 24

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

    Week 24

Study Arms (3)

TA-7284 Low

EXPERIMENTAL
Drug: TA-7284 Low

TA-7284 High

EXPERIMENTAL
Drug: TA-7284 High

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TA-7284 LowDRUG

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

TA-7284 Low
TA-7284 HighDRUG

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

TA-7284 High
PlaceboDRUG

The patients will receive Placebo orally for 24 weeks.

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Reserch site

Chūbu, Japan

Location

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Reserch site

Shikoku, Japan

Location

Reserch site

Tōhoku, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25010793DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Nobuya Inagaki, M.D.

    Kyoto University, Graduate School of Medicine

    STUDY DIRECTOR

  • Kazuoki Kondo, M.D.

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 10, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 8, 2026

Results First Posted

June 5, 2014

Record last verified: 2025-12

Locations

JP(5)