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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Teneligliptin + Sulfonylurea; Drug: Teneligliptin

• Registration Number: NCT02314637
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Results First Submitted: 2014-12-12
• Results First Submitted QC: 2014-12-24
• Results First Posted: 2015-01-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teneligliptin + Sulfonylurea	Teneligliptin + Sulfonylurea	Teneligliptin for 52 weeks in combination with sulfonylurea
Teneligliptin	Teneligliptin	Teneligliptin for 52 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	52 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Week 52	Baseline and Week 52
Change From Baseline in HbA1c at Week 52	Baseline and Week 52

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Shikoku, Japan