Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: biguanide; Drug: glinide; Drug: teneligliptin; Drug: alpha-glucosidase inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301833

3000-A14

Details and patient eligibility

About

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

Enrollment: 462 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) 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
• Patients whose HbA1c is between 6.5% - 10.0%
• 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 habitual excessive alcohol consumption.
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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462 participants in 4 patient groups

teneligliptin

Experimental group

Description:

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )

Treatment:

Drug: teneligliptin

teneligliptin and glinide

Experimental group

Description:

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide

Treatment:

Drug: teneligliptin

Drug: glinide

teneligliptin and biguanide

Experimental group

Description:

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide

Treatment:

Drug: teneligliptin

Drug: biguanide

teneligliptin and alpha-glucosidase inhibitor

Experimental group

Description:

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor

Treatment:

Drug: alpha-glucosidase inhibitor

Drug: teneligliptin