NCT02227849

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

4 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

August 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 14, 2019

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

August 26, 2014

Results QC Date

November 19, 2018

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

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

    52 Weeks

Secondary Outcomes (4)

  • Change in Percentage of HbA1c

    Baseline, 52 Weeks

  • Change in Fasting Plasma Glucose

    Baseline, 52 Weeks

  • Percentage Change in Body Weight

    Baseline, 52 Weeks

  • Change in Blood Pressure

    Baseline, 52 Weeks

Study Arms (1)

Canagliflozin (TA-7284) ＋GLP-1 analogue

EXPERIMENTAL
Drug: Canagliflozin (TA-7284)Drug: GLP-1 analogue

Interventions

Canagliflozin (TA-7284)DRUG

The patients will receive Canagliflozin orally for 52 weeks

Canagliflozin (TA-7284) ＋GLP-1 analogue
GLP-1 analogueDRUG
Canagliflozin (TA-7284) ＋GLP-1 analogue

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Reserch site

Chūbu, Japan

Location

Reserch site

Hokkaido, Japan

Location

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Related Publications (1)

  • Harashima SI, Inagaki N, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Watanabe Y. Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study. Diabetes Obes Metab. 2018 Jul;20(7):1770-1775. doi: 10.1111/dom.13267. Epub 2018 Mar 24.

    PMID: 29473709RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

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, Professor

    Kyoto University, Graduate School of Medicine

    STUDY DIRECTOR

  • Kazuoki Kondo, MD

    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 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 8, 2026

Results First Posted

March 14, 2019

Record last verified: 2025-12

Locations

JP(4)