Clinical trial NCT00971243: Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Official title: A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 448
Sex: ALL
Minimum age (years): 18
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 safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients who are aged ≧ 18 years old.
* Patients whose HbA1c is ≧ 7.0 % and \< 10.0%.
* Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
* Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion Criteria:

* Patients with type 1 diabetes or secondary form of diabetes.
* Patients with heart failure symptoms.
* Patients with serious diabetic complications.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are the excessive alcohol addicts.
* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Adverse Events, Laboratory Tests, Vital Signs, Etc.
timeFrame: Weeks 24, 52
Other outcomes:
Locations:
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Falkensee
country: Germany
city: Hamburg
country: Germany
city: Karlsruhe
country: Germany
city: Kiel
country: Germany
city: Ludwigshafen
country: Germany
city: Lübeck
country: Germany
city: Mainz
country: Germany
city: Budapest
country: Hungary
city: Békéscsaba
country: Hungary
city: Gyöngyös
country: Hungary
city: Kaposvár
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Semmelweis
country: Hungary
city: Szentes
country: Hungary
city: Szigetvár
country: Hungary
city: Ádám
country: Hungary
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Leszno
country: Poland
city: Lodz
country: Poland
city: Niemodlin
country: Poland
city: Plock
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Galati
country: Romania
city: Ploiesti
country: Romania
city: Timisoara
country: Romania
city: Timis
country: Romania
city: Addlestone
country: United Kingdom
city: Ayr
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: East Sussex
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Oldham
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Royal Bournemouth Hospital
name: David Kerr, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.