Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314637
• Other study ID #: 3000-A8
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2014
• Last updated: July 29, 2015
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug

• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug

• HbA1c criteria:

• monotherapy: 6.9% - 10.5%

• combination therapy with Sulfonylurea: 7.4 - 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, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)

• Patients who are accepting treatments of arrhythmias

• Patients with serious diabetic complications

• Patients who are the excessive alcohol addicts

• Patients with severe hepatic disorder or severe renal disorder

• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Teneligliptin
Teneligliptin for 52 weeks
• Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea

Locations

Country	Name	City	State
Japan	Reserch site	Shikoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.	52 weeks	Yes
Secondary	Change From Baseline in HbA1c at Week 52		Baseline and Week 52	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 52		Baseline and Week 52	No