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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Canagliflozin (TA-7284); Drug: GLP-1 analogue

• Registration Number: NCT02227849
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2018-11-19
• Results First Submitted QC: 2018-11-19
• Results First Posted: 2019-03-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canagliflozin (TA-7284) ＋GLP-1 analogue	Canagliflozin (TA-7284)	-
Canagliflozin (TA-7284) ＋GLP-1 analogue	GLP-1 analogue	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Percentage of HbA1c	Baseline, 52 Weeks
Change in Fasting Plasma Glucose	Baseline, 52 Weeks
Percentage Change in Body Weight	Baseline, 52 Weeks
Change in Blood Pressure	Baseline, 52 Weeks

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Kinki, Japan