Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo / Teneli (Teneligliptin) + pio (pioglitazone)
Drug: Teneli / Teneli + pio

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026194
3000-A7

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.

Enrollment

204 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who are 20 - 75 years old 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% and 10.0% Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

204 participants in 2 patient groups, including a placebo group

Placebo / Teneli + Pio
Placebo Comparator group
Treatment:
Drug: Placebo / Teneli (Teneligliptin) + pio (pioglitazone)
Teneli / Teneli + pio
Experimental group
Treatment:
Drug: Teneli / Teneli + pio

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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