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Clinical Trial Details

Trial ID: L3303
Source ID: NCT01069965
Associated Drug: Bgp-15 100 Mg Qd
Title: Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: BGP-15 100 mg QD|DRUG: BGP-15 100 mg BID|DRUG: Placebo BID|DRUG: BGP-15 200 mg QD|DRUG: BGP-15 200 mg BID|DRUG: BGP-15 400 mg QD
Outcome Measures: Primary: Change from Baseline in Glycosylated Hemoglobin at Week 13, Baseline and Week 13 | Secondary: Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13, Baseline and Weeks 4, 8, and 13|Change from Baseline in Plasma Glucose at Week 13, Baseline and Week 13|Cardiovascular and metabolic biomarkers at Baseline and 13 weeks, Baseline and Week 13
Sponsor/Collaborators: Sponsor: N-Gene Research Laboratories, Inc. | Collaborators: Integrium|Msource Medical Development GmbH|Kinexum LLC|Thermo Fisher Scientific, Inc|Haupt Pharma Wülfing GmbH|Barc NV
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 196
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2011-10
Results First Posted:
Last Update Posted: 2014-09-29
Locations: Andrew J. Lewin Medical Corporation DBA National Research Institute, Los Angeles, California, 90057, United States|Center for Clinical Trials, LLC., Paramount, California, 90723, United States|Orange County Research Center, Tustin, California, 92780, United States|Creekside Endocrine Associates PC, Denver, Colorado, 80209, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Atlanta Pharmaceutical Research, Decatur, Georgia, 30033, United States|ICCT Research International, Inc., Chicago, Illinois, 60611, United States|Medstar Health Research Institute, Hyattsville, Maryland, 20782, United States|The Center for Pharmaceutical Research, P.C., Kansas City, Missouri, 64114, United States|Nevada Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|New Hanover Medical Research, Wilmington, North Carolina, 28401, United States|Piedmont Medical Research, LLC., Winston-Salem, North Carolina, 27103, United States|Upstate Pharmaceutical Research, Greenville, South Carolina, 29615, United States|Mountain View Clinical Research, Greer, South Carolina, 29651, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 29687, United States|Athens Medical Group, Athens, Tennessee, 37303, United States|Juno Research, LLC., Houston, Texas, 77074, United States|Juno Research, LLC., Katy, Texas, 77451, United States|Cetero Research-San Antonio, San Antonio, Texas, 78229, United States|Diabetespraxis Bad Mergentheim, Bad Mergentheim, 97980, Germany|Praxis Dr. Schätzl, Großheirath-Rossach, 96269, Germany|Universitätsklinikum Köln, Köln, 50937, Germany|Schwerpunktpraxis Diabetes, Neuwied, 56564, Germany|Diabetologische Schwerpunktpraxis, Siegen, 57072, Germany|DRUG Research Center Hungary Kft., Balatonfüred, 8230, Hungary|Semmelweis University 2nd Clinic for Internal Medicine, Budapest, 1088, Hungary|Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism, Győr, 9024, Hungary|Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic, Szentes, 6600, Hungary|Zala County Hospital Department of Diabetology, Zalaegerszeg, 8900, Hungary
URL: https://clinicaltrials.gov/show/NCT01069965

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress