Clinical trial NCT01026194: Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Official title: A Phase III Study of MP-513 in Combination With Thiazolidinedione in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: at Week 0 and Week 12
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: at Week 0 and Week 12
measure: Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
timeFrame: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
timeFrame: at Week 0 and Week 12
Other outcomes:
Locations:
city: Shinjukuku
country: Japan
state: Tokyo
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Kondo K. Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):576-84. doi: 10.1111/jdi.12092. Epub 2013 May 27.
citation: Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.