Type 2 Diabetes MellitusPhase 4NCT02227849
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Canagliflozin (TA-7284) and GLP-1 analogue in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 4 sites in Japan.
Trial 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. 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 GLP-1 analogue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 4 sitesJapan
- Study dates
- Aug 2014to Mar 2016
- Phase
- Phase 4
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 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
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
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- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Reserch site
Chūbu
Reserch site
Hokkaido
Reserch site
Kanto
Reserch site
Kinki
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 GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus
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.
Read the detailed description
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Canagliflozin (TA-7284), GLP-1 analogue
- 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 52 weeks
GLP-1 analogueDrug
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin (TA-7284) ＋GLP-1 analogue | Experimental | Not described Receives: Drug: Canagliflozin (TA-7284); Drug: GLP-1 analogue |
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: 52 Weeks
Secondary outcomes (4)
Change in Percentage of HbA1c
Measured: Baseline, 52 Weeks
Change in Fasting Plasma Glucose
Measured: Baseline, 52 Weeks
Percentage Change in Body Weight
Measured: Baseline, 52 Weeks
Change in Blood Pressure
Measured: Baseline, 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuya Inagaki, Professor, Study director, Kyoto University, Graduate School of MedicineKazuoki Kondo, MD, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227849
- Sponsor's protocol ID
- TA-7284-12
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2014
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29473709