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Clinical Trial Details

Trial ID: L4743
Source ID: NCT00971243
Associated Drug: Mp-513 Lowest Dose And Metformin
Title: Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00971243/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MP-513 Lowest Dose and Metformin|DRUG: MP-513 Low Dose and Metformin|DRUG: MP-513 Medium Dose and Metformin|DRUG: MP-513 High Dose and Metformin|DRUG: Placebo and Metformin
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 24, The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate., Baseline and Week 24 | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint., Baseline and Week 24|Adverse Events, Laboratory Tests, Vital Signs, Etc., Weeks 24, 52
Sponsor/Collaborators: Sponsor: Mitsubishi Tanabe Pharma Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 448
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-08
Completion Date: 2011-04
Results First Posted: 2014-09-01
Last Update Posted: 2014-09-01
Locations: Aalborg, Denmark|Ballerup, Denmark|Vejle, Denmark|Falkensee, Germany|Hamburg, Germany|Karlsruhe, Germany|Kiel, Germany|Ludwigshafen, Germany|Lübeck, Germany|Mainz, Germany|Budapest, Hungary|Békéscsaba, Hungary|Gyöngyös, Hungary|Kaposvár, Hungary|Miskolc, Hungary|Nyíregyháza, Hungary|Semmelweis, Hungary|Szentes, Hungary|Szigetvár, Hungary|Ádám, Hungary|Kaunas, Lithuania|Klaipeda, Lithuania|Vilnius, Lithuania|Gdansk, Poland|Krakow, Poland|Leszno, Poland|Lodz, Poland|Niemodlin, Poland|Plock, Poland|Warszawa, Poland|Wroclaw, Poland|Brasov, Romania|Bucharest, Romania|Bucuresti, Romania|Galati, Romania|Ploiesti, Romania|Timisoara, Romania|Timis, Romania|Addlestone, United Kingdom|Ayr, United Kingdom|Bournemouth, United Kingdom|East Sussex, United Kingdom|Edinburgh, United Kingdom|Oldham, United Kingdom|York, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00971243

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details