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

Phase 4

Completed

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

• Registration Number: NCT02622113
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Detailed Description

This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• 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: 139

Inclusion Criteria

• Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)

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Exclusion Criteria

• Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
• Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
• Patients with serious renal or hepatic disease
• Patients who are the excessive alcohol addicts
• 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) ＋insulin	Canagliflozin (TA-7284)	-
Canagliflozin (TA-7284) ＋insulin	Insulin	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)	Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Percentage of HbA1c	Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Change in Fasting Plasma Glucose	Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Percentage Change in Body Weight	Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Tohoku, Japan