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Clinical Trial Details

Trial ID: L6368
Source ID: NCT00353587
Associated Drug: Mbx-102
Title: Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: MBX-102|DRUG: MBX-102|DRUG: MBX-102|DRUG: Placebo|DRUG: Actos
Outcome Measures: Primary: Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c|Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema |
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 396
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-05
Completion Date: 2007-11
Results First Posted:
Last Update Posted: 2015-05-01
Locations: NEA Clinic, Jonesboro, Arkansas, 72401, United States|Associated Pharmaceutical Research Center, Inc., Buena Park, California, 90620, United States|The Intermed Group, Los Angeles, California, 90017, United States|LAC/USC Medical Center, Los Angeles, California, 90033, United States|International Research Associates, LLC, Miami, Florida, 33156, United States|Suncoast Clinical Research, Inc., Palm Harbor, Florida, 34684, United States|Andres Patron DO PA, Pembroke Pines, Florida, 33026, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Clinical Investigation Specialists, Inc., Gurnee, Illinois, 60031, United States|Olive Branch Research, Olive Branch, Mississippi, 38654, United States|Optimed Research, LLC, Columbus, Ohio, 43235, United States|Radiant Research - Greer, Greer, South Carolina, 29651, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Mercury Pharma Services, Houston, Texas, 77081, United States|Diabetes Center of the Southwest, Midland, Texas, 79705, United States|Diabetes & Glandular Disease Research Associates, P.A., San Antonio, Texas, 78229, United States|McGuire VA Medical Center, Richmond, Virginia, 23249, United States|National Clinical Research, Richmond, Virginia, 23294, United States|Consultorio Integral de Atencion al Diabetico (CIAD), Buenos Aires, B1708IFF, Argentina|CIMEL, Buenos Aires, B1824KAJ, Argentina|Centro de Atencion Integral en Diabetes, Endocrinologica y Metabolismo, Buenos Aires, B6740CWC, Argentina|Fundacion CIDEA, Buenos Aires, C1121ABE, Argentina|Sanatorio Municipal Dr. Julio Mendez, Buenos Aires, C1405CNF, Argentina|Instituto Medico Especializado, Buenos Aires, C1405CWB, Argentina|Hospital Thompson, Buenos Aires, CP1650, Argentina|Clinica Dleta Zarate, Buenos Aires, Argentina|Hospital Privado de Comunidad, Buenos Aires, Argentina|Consultorios Asociados de Endocrinologia, Capital Federal, Argentina|Instituto Latinoamericano de Investigaciones Clinicas, Cordoba, X5000BNB, Argentina|Sanatorio Parque, Cordoba, X5000IKK, Argentina|Fundacion Marcelino Rusculleda Batlle, Cordoba, Argentina|Instituto de Clinica Medica y Diabetes, Mendoza, M5519XAC, Argentina|Policlio Modelo de Cipoletti, Rio Negro, R8324BSS, Argentina|Hospital San Bernardo, Salta, A4406CLA, Argentina|CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan Capital, Argentina|Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, Andhra Pradesh, 500082, India|Bharti Research Institute of Diabetes & Endocrinology, Karnal, Haryana, India|Amrita Institute of Medical Sciences, Cochin, Kerala, 682026, India|Kasturba Medical College Hospital, Attavar, Mangalore, 575001, India|Sterling Hospital, Ahmedabad, India|St. John's Medical College Hospital, Bangalore, 560034, India|M.S. Ramaih Medical College & Hospital, Bangalore, 560054, India|Diacon Hospital, Bangalore, India|Sri Ramachandra Medical Centre, Chennai, 600 116, India|Dr. V. Seshiah Diabetes Care & Research Institute, Chennai, India|Apollo Gleneages/Dept. of Endocrinology, Kolkata, India|Diabetes Care and Research Center, Maharashtra, 411011, India|Kasturba Hospital, Manipal, 576104, India|Chowpatty Medical Center, Mumbai, India|Mediheights Healthcare Pvt. Ltd., Mumbai, India|KEM Hospital, Pune, 411 011, India|Kerala Institute of Medical Sciences, Trivandrum, India|Christian Medical College Hospital, Vellore, 632004, India|Endocrinology Institute, Haemek Medical Center, Afula, Israel|Barzilai Medical Center, Ashkelon, Israel|Soroka Medical Center, BeEr-Sheva, 84101, Israel|Rambam Medical Center, Haifa, 31996, Israel|Linn Medical Center, Haifa, 34780, Israel|Wolfson Medical Center, Holon, 58100, Israel|Hadassah University Hospital, Jerusalem, 91120, Israel|Clalit Health Services, Jerusalem, 93106, Israel|Institution of Diabetes and Metabolism, Nahariya, 22100, Israel|Endocrinology & Diabetes Institute, Petach Tikva, Israel|Department of Endocrinology, Ziv Medical Center, Safed, 13091, Israel|Institute of Metabolic Diseases, Tel Aviv, Israel|Zamenhoff Medical Center, Tel-Aviv, 64353, Israel|Assaf Haroffe Medical Center, Zrifin, Israel
URL: https://clinicaltrials.gov/show/NCT00353587