Type 2 Diabetes MellitusPhase 4NCT02622113

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

A Phase 4 study testing Canagliflozin (TA-7284) and Insulin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Canagliflozin (TA-7284) and Insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 7 sitesJapan
Study dates: Dec 2014to Apr 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Reserch site
Chūbu
Reserch site
Chugoku
Reserch site
Hokkaido
Reserch site
Kanto
Reserch site
Kinki
Reserch site
Kyushu
Reserch site
Tōhoku

Other trials in Japan

About this study

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

Read the detailed description

This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: Canagliflozin (TA-7284), Insulin
Keywords: insulin resistance
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Canagliflozin (TA-7284)Drug
The patients will receive Canagliflozin orally for 36 weeks
InsulinDrug

Study groups in NCT02622113
Study group	Role	What they receive
Canagliflozin (TA-7284) ＋insulin	Experimental	Not described Receives: Drug: Canagliflozin (TA-7284); Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Measured: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

Secondary outcomes (3)

Change in Percentage of HbA1c
Measured: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Change in Fasting Plasma Glucose
Measured: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Percentage Change in Body Weight
Measured: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Apr 2016

First posted4 Dec 2015 (estimated)
Study startDec 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02622113
Sponsor's protocol ID: TA-7284-13
Status last verified: Dec 2025
First submitted: 2 Dec 2015
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29110384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02622113
Acronym / sponsor ID: TA-7284-13
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 4 Dec 2015 (estimated)
Results: Posted 14 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Canagliflozin (TA-7284) ＋insulin	Experimental	Drug: Canagliflozin (TA-7284), Drug: Insulin

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Canagliflozin (TA-7284)The patients will receive Canagliflozin orally for 36 weeks	Drug	Canagliflozin (TA-7284) ＋insulin
Insulin	Drug	Canagliflozin (TA-7284) ＋insulin

Primary outcome

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

3 secondary outcomes

Change in Percentage of HbA1c
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Change in Fasting Plasma Glucose
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Percentage Change in Body Weight
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Results and safety

Results posted to the registry on 14 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/CANA + Insulin	67	62
CANA/CANA + Insulin	76	66

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

Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks. Count of participants. Unit: Participants

Measure	Placebo/CANA + Insulin n = 67	CANA/CANA + Insulin n = 75
Serious Adverse Event	7	7
Adverse Event	57	69

Population analysed: One patient of CANA/CANA group who mistakenly received placebo during TA-7284-11 study, did not continued this study. This patient was included in the full analysis set and was not included in the safety analysis set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/CANA + Insulin	7 of 67 (10.4%)	49 of 67 (73.1%)	Not reported
CANA/CANA + Insulin	7 of 75 (9.3%)	56 of 75 (74.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29110384Inagaki 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.

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Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kazuoki Kondo, MD study director

Tanabe Pharma Corporation

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin (TA-7284) and Insulin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 7 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) (time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622113, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.