Type 2 Diabetes MellitusPhase 4NCT02220920

Efficacy and 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

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration. 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?: Yes, some participants may receive a placebo
How many people: 146 participants
Where: 7 sitesJapan
Study dates: Aug 2014to Jul 2015
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 who has been receiving a stable dose and regimen of insulin 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 ≥7.5% and <10.5%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Who cannot join

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 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: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Read the detailed description

This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: Canagliflozin (TA-7284), Placebo, 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 16 weeks
PlaceboDrug
The patients will receive Placebo orally for 16 weeks
InsulinDrug

Study groups in NCT02220920
Study group	Role	What they receive
Canagliflozin (TA-7284) ＋insulin	Experimental	Not described Receives: Drug: Canagliflozin (TA-7284); Drug: Insulin
Placebo＋insulin	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Insulin

What is being measured

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

Change in HbA1c From Baseline
Measured: baseline and Week 16

Secondary outcomes (4)

Change in Fasting Plasma Glucose
Measured: baseline and Week 16
Percent Change in Body Weight
Measured: baseline and Week 16
Change in Blood Pressure
Measured: baseline and Week 16
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
Measured: Week 16

Timeline

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

Aug 2014Jul 2015

First posted20 Aug 2014 (estimated)
Study startAug 2014
Primary completionJul 2015
Study completionJul 2015

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02220920
Sponsor's protocol ID: TA-7284-11
Status last verified: Dec 2025
First submitted: 19 Aug 2014
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4.
PubMed 27316668

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: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02220920
Acronym / sponsor ID: TA-7284-11
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 20 Aug 2014 (estimated)
Results: Posted 15 Dec 2016

Clinical summary

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

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

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

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who has been receiving a stable dose and regimen of insulin 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 ≥7.5% and <10.5%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Key exclusion criteria (8 listed)

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

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 16 weeks	Drug	Canagliflozin (TA-7284) ＋insulin
PlaceboThe patients will receive Placebo orally for 16 weeks	Drug	Placebo＋insulin
Insulin	Drug	Canagliflozin (TA-7284) ＋insulin, Placebo＋insulin

Primary outcome

Change in HbA1c From Baseline
Time frame: baseline and Week 16

4 secondary outcomes

Change in Fasting Plasma Glucose
Time frame: baseline and Week 16
Percent Change in Body Weight
Time frame: baseline and Week 16
Change in Blood Pressure
Time frame: baseline and Week 16
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
Time frame: Week 16

Results and safety

Results posted to the registry on 15 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canagliflozin (TA-7284) ＋Insulin	76	73
Placebo＋Insulin	70	67

Primary outcome: Change in HbA1c From Baseline

Time frame: baseline and Week 16. Least squares mean (Standard Error). Unit: Percent

Measure	Canagliflozin (TA-7284) ＋Insulin n = 76	Placebo＋Insulin n = 70
Value	-0.97 (0.08)	0.13 (0.08)

Canagliflozin (TA-7284) ＋Insulin vs Placebo＋Insulin: Least-Squares Mean Difference: -1.10 (95% CI -1.33 to -0.87), p <0.001, ANCOVA

Population analysed: Full analysis set, last observation carried forward

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canagliflozin (TA-7284) ＋Insulin	3 of 75 (4%)	39 of 75 (52%)	Not reported
Placebo＋Insulin	1 of 71 (1.4%)	34 of 71 (47.9%)	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 27316668Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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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 4 inclusion and 8 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. Some participants in this study may receive a placebo. 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 15 Dec 2016). 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?

Change in HbA1c From Baseline (time frame: baseline and Week 16). 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 NCT02220920, 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.