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Clinical Trial Details

Trial ID: L6646
Source ID: NCT00873561
Associated Drug: Nbi-6024
Title: A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: NBI-6024
Outcome Measures: Primary: To assess the effect of repeated administrations of NBI-6024 on endogenous insulin production as measured by C-peptide levels in adult and adolescent patients with new onset type 1 diabetes mellitus, monthly assessments, up to 24 months (end of study) | Secondary: To examine the effects of repeated administrations of NBI-6024 on insulin usage, glycemic control, and immune function (immunodynamics and pharmacodynamics) To examine the safety and tolerability of repeated administrations of NBI-6024, monthly assessments, up to 24 months (end of study)
Sponsor/Collaborators: Sponsor: Neurocrine Biosciences
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1
Enrollment: 188
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2001-12
Completion Date: 2006-07
Results First Posted:
Last Update Posted: 2009-04-01
Locations: Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada|Center Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada|Centre de recherche clinique de Laval, Laval, Canada|University Hospital and School of Medicine, Olomouc, Czech Republic|Faculty Hospital Motol, Prague, Czech Republic|Helsinki University Hospital, Helsinki, Finland|Hôpital Debrousse, Lyons, France|Hôpital St Vincent de Paul, Paris, France|Diabetes Center for Children and Adolescents, Hannover, Germany|Institut für Diabetesforschung, Munchen, Germany|New Groote Schuur Hospital, Cape Town, South Africa|Parklands Medical Center, Durban, South Africa|Center for Diabetes and Endocrinology, Johannesburg, South Africa|Donald Gordon Medical Center, Johannesburg, South Africa|Medigate Medical Center, KwaZulu Natal, South Africa|Helderberg Diabetic Clinic and Practice, Somerset West, South Africa|Hospital Clinic de Barcelona, Barcelona, Spain|Hospital de Cruces, Cruces-Baracado, Spain|Hospital Materno-Infantil, Malaga, Spain|University Hospital Virgen del Rocío, Sevilla, Spain|Maternal and Child Health Services 2, Dundee, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00873561

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