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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354222
• Other study ID #: MT-2412-J02
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Canagliflozin

• Teneligliptin

• Placebo

Locations

Country	Name	City	State
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki
Japan	Reserch site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Gouda M, Iijima H, Watanabe Y. Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)	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.	Baseline, 24 Weeks
Secondary	Change From Baseline in Fasting Plasma Glucose Level	The change from baseline in fasting plasma glucose level collected at Week 24.	Baseline, 24 Weeks
Secondary	Percentage Change in Body Weight From Baseline	The percentage change from baseline in body weight collected at Week 24.	Baseline, 24 Weeks
Secondary	Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)	The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.	0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Secondary	Change From Baseline in 2-hour Postprandial Plasma Glucose Level	The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.	2 Hours Postprandial, at Baseline and 24 Weeks