NCT01022112

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

6 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

November 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.8 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

10 months

First QC Date

November 29, 2009

Results QC Date

March 26, 2014

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

TA-7284JNJ-28431754CanagliflozinType 2 diabetes mellitusSodium Glucose Co-transporter (SGLT2 inhibitor)

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (2)

  • Fasting Blood Glucose, Body Weight

    12 weeks

  • Safety and Tolerability

    14 weeks

Study Arms (5)

TA-7284-Low

EXPERIMENTAL
Drug: TA-7284-Low

TA-7284-Low-middle

EXPERIMENTAL
Drug: TA-7284-Low-middle

TA-7284-High-middle

EXPERIMENTAL
Drug: TA-7284-High-middle

TA-7284-High

EXPERIMENTAL
Drug: TA-7284-High

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TA-7284-LowDRUG

TA-7284-Low

TA-7284-Low
TA-7284-Low-middleDRUG

TA-7284-Low-middle

TA-7284-Low-middle
TA-7284-HighDRUG

TA-7284-High

TA-7284-High
TA-7284-High-middleDRUG

TA-7284-High-middle

TA-7284-High-middle
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research site

Chugoku, Japan

Location

Research site

Kanto, Japan

Location

Research site

Kinki, Japan

Location

Research site

Kyushu, Japan

Location

Research site

Shikoku, Japan

Location

Research site

Tōhoku, Japan

Location

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

  • Tadashi Yoshida, 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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 8, 2026

Results First Posted

June 5, 2014

Record last verified: 2025-12

Locations

JP(6)