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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622113
• Other study ID #: TA-7284-13
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: April 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

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

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

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 36 weeks
• Insulin

Locations

Country	Name	City	State
Japan	Reserch site	Chubu
Japan	Reserch site	Chugoku
Japan	Reserch site	Hokkaido
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki
Japan	Reserch site	Kyushu
Japan	Reserch site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Inagaki N, Harashima SI, Kaku K, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Iijima H. Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Apr;20(4):812-8 — 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)		Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Secondary	Change in Percentage of HbA1c		Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Secondary	Change in Fasting Plasma Glucose		Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Secondary	Percentage Change in Body Weight		Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks