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Clinical Trial Details

Trial ID: L3245
Source ID: NCT00672386
Associated Drug: Jnj16269110
Title: A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Diabetes Mellitus|Endocrine System Diseases|Nutritional and Metabolic Diseases
Interventions: DRUG: JNJ16269110|DRUG: JNJ16269110|DRUG: JNJ16269110|DRUG: Placebo|DRUG: Metformin|OTHER: Dietary Counseling
Outcome Measures: Primary: Mean change in HbA1c from baseline to week 12, baseline, week 4, 6, 8, 10 and 12 | Secondary: Changes in fasting plasma glucose, every 2 weeks|Changes in body weight, every 2 weeks|Changes in plasma lipids, baseline, week 6 and 12|Changes in systolic and diastolic blood pressure, every 2 weeks|Changes in insulin sensitivity and beta cell function (homeostatic model assessment 2 - HOMA-2 and MMTT); Changes in GLP-1 (glucagon-like peptide 1) and PYY (peptide tyrosine tyrozine) levels in the MMTT; Changes in insulin and glucagon, baseline and Week 12
Sponsor/Collaborators: Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 352
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-12
Completion Date: 2008-09
Results First Posted:
Last Update Posted: 2014-07-14
Locations: Edegem, Belgium|Hellerup N/A, Denmark|Vipperroed, Denmark|Helsinki, Finland|Hyvinkaa, Finland|Kuopio, Finland|Oulu, Finland|Berlin Buch, Germany|Dresden, Germany|Düsseldorf, Germany|Hamburg, Germany|Mainz, Germany|Munchen, Germany|Ulm, Germany|Bangalore, India|Chennai, India|Hyderabad, India|Mumbai, India|Nagpur, India|Pune, India|Breda, Netherlands|Eindhoven, Netherlands|Leiden, Netherlands|Nijmegen, Netherlands|Rotterdam, Netherlands|Velp Gld, Netherlands|Zoetermeer, Netherlands|Oslo, Norway|Paradis N/A, Norway|Bialystok, Poland|Bydgoszcz, Poland|Elblag, Poland|Kutno 001, Poland|Lodz, Poland|Olsztyn, Poland|Pruszkow, Poland|Torun, Poland|Warszawa, Poland|Wroclaw, Poland|Zielona Gora, Poland|Moscow, Russian Federation|Saratov, Russian Federation|St Petersburg N/A, Russian Federation|St-Petersburg, Russian Federation|Göteborg, Sweden|Härnösand, Sweden|Linköping, Sweden|Lund, Sweden|Stockholm, Sweden|Ängelholm N/A, Sweden|Örebro, Sweden|Bangor, United Kingdom|Belfast, United Kingdom|Birmingham, United Kingdom|Cambridge, United Kingdom|Cardiff, United Kingdom|Clydebank, United Kingdom|Dundee, United Kingdom|Liverpool, United Kingdom|London, United Kingdom|Randalstown, United Kingdom|Reading, United Kingdom|Salford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00672386

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress