NCT02354235CompletedPhase 3
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)
Tanabe Pharma Corporation3 sites in 1 country138 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 138
- Locations
- 3
- Primary Endpoint
- Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women who are 20 - 75 years old
- •HbA1c of ≥7.0% and <10.5%
- •FPG of ≤ 270 mg/dL
- •Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period
Exclusion Criteria
- •Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
- •Patients with serious diabetic complications
- •Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- •Patients with severe hepatic disorder or severe renal disorder.
Arms & Interventions
Canagliflozin + Teneligliptin
Experimental
Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Placebo + Teneligliptin
Placebo Comparator
Patients receive placebo for 24 weeks in combination with Teneligliptin.
Outcomes
Primary Outcomes
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Time Frame: Baseline, 24 Weeks
The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose Level(Baseline, 24 Weeks)
- Percentage Change in Body Weight From Baseline(Baseline, 24 Weeks)
- Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)(0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks)
- Change From Baseline in 2-hour Postprandial Plasma Glucose Level(2 Hours Postprandial, at Baseline and 24 Weeks)
Investigators
Study Sites (3)
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