NCT02622113

Brief Summary

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

7 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

December 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 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

1.3 years

First QC Date

December 2, 2015

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)

    Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

Secondary Outcomes (3)

  • Change in Percentage of HbA1c

    Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

  • Change in Fasting Plasma Glucose

    Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

  • Percentage Change in Body Weight

    Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Study Arms (1)

Canagliflozin (TA-7284) ＋insulin

EXPERIMENTAL
Drug: Canagliflozin (TA-7284)Drug: Insulin

Interventions

Canagliflozin (TA-7284)DRUG

The patients will receive Canagliflozin orally for 36 weeks

Canagliflozin (TA-7284) ＋insulin
InsulinDRUG
Canagliflozin (TA-7284) ＋insulin

Eligibility Criteria

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

You may qualify if:

  • Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)

You may not qualify if:

  • Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
  • Patients with serious renal or hepatic disease
  • Patients who are the excessive alcohol addicts
  • 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 (7)

Reserch site

Chugoku, Japan

Location

Reserch site

Chūbu, Japan

Location

Reserch site

Hokkaido, Japan

Location

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Reserch site

Kyushu, Japan

Location

Reserch site

Tōhoku, Japan

Location

Related Publications (1)

  • Inagaki N, Harashima SI, Kaku K, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Iijima H. Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Apr;20(4):812-820. doi: 10.1111/dom.13152. Epub 2017 Dec 5.

    PMID: 29110384RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

CanagliflozinInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydratesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

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

Study Officials

  • 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

December 2, 2015

First Posted

December 4, 2015

Study Start

December 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 8, 2026

Results First Posted

March 14, 2019

Record last verified: 2025-12

Locations

JP(7)