Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Teneligliptin; Drug: Placebo; Drug: Canagliflozin

• Registration Number: NCT02354235
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-11-16
• Results First Submitted QC: 2017-11-16
• Results First Posted: 2018-08-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin + Teneligliptin	Teneligliptin	Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Placebo + Teneligliptin	Placebo	Patients receive placebo for 24 weeks in combination with Teneligliptin.
Canagliflozin + Teneligliptin	Canagliflozin	Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Placebo + Teneligliptin	Teneligliptin	Patients receive placebo for 24 weeks in combination with Teneligliptin.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)	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 Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose Level	Baseline, 24 Weeks	The change from baseline in fasting plasma glucose level collected at Week 24.
Percentage Change in Body Weight From Baseline	Baseline, 24 Weeks	The percentage change from baseline in body weight collected at Week 24.
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	The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Change From Baseline in 2-hour Postprandial Plasma Glucose Level	2 Hours Postprandial, at Baseline and 24 Weeks	The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Tohoku, Japan