Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220907
• Other study ID #: MT-2412-J01
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• 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 safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Men or women age =20 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 12 weeks before treatment 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:
• Teneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.

Locations

Country	Name	City	State
Japan	Research site	Chubu
Japan	Research site	Chugoku
Japan	Research site	Hokkaido
Japan	Research site	Kanto
Japan	Research site	Kyushu
Japan	Research 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, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		52 Weeks
Secondary	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 52.	Baseline, 52 Weeks
Secondary	Change From Baseline in Fasting Plasma Glucose Level	The change from baseline in fasting plasma glucose level collected at Week 52.	Baseline, 52 Weeks
Secondary	Percentage Change in Body Weight From Baseline	The percentage change from baseline in body weight collected at Week 52.	Baseline, 52 Weeks