Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT02227849

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-03-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Canagliflozin (TA-7284) ＋GLP-1 analogue

Group Type: EXPERIMENTAL

Canagliflozin (TA-7284)

Intervention Type: DRUG

The patients will receive Canagliflozin orally for 52 weeks

GLP-1 analogue

Intervention Type: DRUG

Interventions

Canagliflozin (TA-7284)

The patients will receive Canagliflozin orally for 52 weeks

Intervention Type: DRUG

GLP-1 analogue

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nobuya Inagaki, Professor

Role: STUDY_DIRECTOR

Kyoto University, Graduate School of Medicine

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Reserch site

Chūbu, , Japan

Reserch site

Hokkaido, , Japan

Reserch site

Kanto, , Japan

Reserch site

Kinki, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 29473709 (View on PubMed)

Other Identifiers

TA-7284-12

Identifier Type: -

Identifier Source: org_study_id