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Clinical Trial Details

Trial ID: L5271
Source ID: NCT02537470
Associated Drug: Biphasic Remogliflozin Etabonate
Title: Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
Acronym: BRID
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Diabetes Mellitus, Type 2
Interventions: DRUG: Biphasic Remogliflozin Etabonate|OTHER: Placebo
Outcome Measures: Primary: Glycosylated haemoglobin A1c (HbA1c) at Week 12, 12 weeks | Secondary: HbA1c, at weeks 4, 8 and 12|Fasting plasma glucose (FPG), at Weeks 4, 8 and 12|Insulin, at Weeks 4, 8 and 12|C-peptide, at Weeks 4, 8 and 12|Total Cholesterol, at Weeks 4, 8 and 12|LDL-c, at Weeks 4, 8 and 12|HDL-c, at Weeks 4, 8 and 12|Serum Triglycerides, at Weeks 4, 8 and 12|Body Weight, at Weeks 4, 8 and 12|Waist Circumference, at Weeks 4, 8 and 12|Adverse Events (AE), Over 12 weeks|Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests, 12 weeks
Sponsor/Collaborators: Sponsor: BHV Pharma | Collaborators: Integrium
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 191
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-07
Completion Date: 2016-08
Results First Posted:
Last Update Posted: 2018-01-18
Locations: Advanced Arizona Clinical Research, Tucson, Arizona, 85712, United States|Long Beach Clinical Trials, Long Beach, California, 90806, United States|Long Beach Center for Clinical Research, Long Beach, California, 90807, United States|National Research Institute, Los Angeles, California, 90057, United States|Orange County Research Center, Tustin, California, 92780, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Chase Medical Research, Waterbury, Connecticut, 06708, United States|Medical Research Unlimited, Hialeah, Florida, 33012, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Meridien Research, Tampa, Florida, 33634, United States|eStudySite, Las Vegas, Las Vegas, Nevada, 89109, United States|Comprehensive Clinical Research, Berlin, New Jersey, 08009, United States|Albuquerque Clinical Trials, Inc, Albuquerque, New Mexico, 87102, United States|Mountain View Clinical Research, Greer, South Carolina, 29651, United States|New Phase Research & Development, Knoxville, Tennessee, 37909, United States|Austin Center for Clinical Research, Austin, Texas, 78756, United States|Padre Coast Clinical Research, Corpus Christi, Texas, 78404, United States|Juno Research, LLC, Houston, Texas, 77074, United States|Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States
URL: https://clinicaltrials.gov/show/NCT02537470

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress