CompletedPhase 4Results posted

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Tanabe Pharma Corporation

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•HbA1c 7-10.5%

Primary endpoint

•Safety and Tolerability

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02227849

Org study IDTA-7284-12

Timeline

Milestones

Study first posted2014-08-28estimated

Results first posted2019-03-14actual

Last update posted2026-01-08actual

Study start2014-08 (month precision)

Primary completion2016-03actual (month precision)

Study completion2016-03actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug

•Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug

•Patients with HbA1c of ≥7.0% and <10.5%

•Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion criteria

•Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)

•Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)

•Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

•Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg

•Patients with serious renal or hepatic disease

•Patients with eGFR of <45 mL/min/1.73 m2

•Patients who are the excessive alcohol addicts

•Patients requiring insulin therapy

•Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percentage Change in Body Weight

Time frame:Baseline, 52 Weeks

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in Percentage of HbA1c

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)

Time frame:52 Weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.