Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
NCT ID: NCT00971243
Last Updated: 2026-01-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
448 participants
INTERVENTIONAL
2009-08-31
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
NCT00823680
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
NCT00511667
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
NCT00798161
A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263
NCT01128621
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
NCT01560481
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MP-513 Lowest Dose and Metformin
MP-513 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Low Dose and Metformin
MP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Medium Dose and Metformin
MP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 High Dose and Metformin
MP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo and Metformin
Placebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MP-513 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanabe Pharma Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Kerr, Dr
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Vejle, , Denmark
Falkensee, , Germany
Hamburg, , Germany
Karlsruhe, , Germany
Kiel, , Germany
Ludwigshafen, , Germany
Lübeck, , Germany
Mainz, , Germany
Ádám, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Gyöngyös, , Hungary
Kaposvár, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Semmelweis, , Hungary
Szentes, , Hungary
Szigetvár, , Hungary
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Gdansk, , Poland
Krakow, , Poland
Leszno, , Poland
Lodz, , Poland
Niemodlin, , Poland
Płock, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Brasov, , Romania
Bucharest, , Romania
Galati, , Romania
Ploieşti, , Romania
Timișoara, , Romania
Timuș, , Romania
Addlestone, , United Kingdom
Ayr, , United Kingdom
Bournemouth, , United Kingdom
East Sussex, , United Kingdom
Edinburgh, , United Kingdom
Oldham, , United Kingdom
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MP-513-E07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.