Clinical trial NCT02622113: Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-04
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
timeFrame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Secondary outcomes:
measure: Change in Percentage of HbA1c
timeFrame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
measure: Change in Fasting Plasma Glucose
timeFrame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
measure: Percentage Change in Body Weight
timeFrame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Reserch site
city: Chugoku
country: Japan
facility: Reserch site
city: Hokkaido
country: Japan
facility: Reserch site
city: Kanto
country: Japan
facility: Reserch site
city: Kinki
country: Japan
facility: Reserch site
city: Kyushu
country: Japan
facility: Reserch site
city: Tohoku
country: Japan
facility: Reserch site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: 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):812-820. doi: 10.1111/dom.13152. Epub 2017 Dec 5.