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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227849
• Other study ID #: TA-7284-12
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2019
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Canagliflozin (TA-7284)
The patients will receive Canagliflozin orally for 52 weeks
• GLP-1 analogue

Locations

Country	Name	City	State
Japan	Reserch site	Chubu
Japan	Reserch site	Hokkaido
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)		52 Weeks
Secondary	Change in Percentage of HbA1c		Baseline, 52 Weeks
Secondary	Change in Fasting Plasma Glucose		Baseline, 52 Weeks
Secondary	Percentage Change in Body Weight		Baseline, 52 Weeks
Secondary	Change in Blood Pressure		Baseline, 52 Weeks