Clinical trial NCT02220920: Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability 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: 2014-08-20
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Detailed description: This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of insulin 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 ≥7.5% 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 who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Primary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: baseline and Week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: baseline and Week 16
measure: Percent Change in Body Weight
timeFrame: baseline and Week 16
measure: Change in Blood Pressure
timeFrame: baseline and Week 16
measure: Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
timeFrame: Week 16
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 S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4.