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Clinical Trial Details

Trial ID: L7085
Source ID: NCT00455598
Associated Drug: Isis 113715
Title: Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ISIS 113715
Outcome Measures: Primary: Change and % change from baseline HbA1c, 13 weeks|Change and % change from baseline fasting glucose (serum and plasma), 13 weeks|Change and % change from baseline seven point glucose profile, 13 weeks|Change and % change from baseline mean fasting and insulin c-peptide, 13 weeks|Change and % change from baseline fasting proinsulin, 13 weeks|Change and % change from baseline proinsulin / insulin ration, 13 weeks|Change and % change from baseline lipid and lipoprotein values: TC, LDL, HDL, TG, VLDL, apoB-100, 13 weeks|Change and % change from baseline Adiponectin, 13 weeks | Secondary: Adverse Events, 13 weeks|Clinical laboratory tests, 13 weeks|12 lead ECG, 13 weeks|vital signs assessments, weight change, physical exams, 13 weeks|concomitant medications, 13 weeks
Sponsor/Collaborators: Sponsor: Ionis Pharmaceuticals, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 88
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-02
Completion Date: 2009-05
Results First Posted:
Last Update Posted: 2009-08-28
Locations: Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Internistyczno, Bialystok, 15-435, Poland|Akademickie Centrum Kliniczne- Szpital Akademii Medycznej w Gdańsku, Gdańsk, 80-952, Poland|Poradnia Neurologiczna i Poradnia, Poznań, 61-289, Poland|Niepubliczny Zakład Opieki, Radom, 26-610, Poland|Indywidualna Specjalistyczna Praktyka Lekarska, Szczecin, 70-361, Poland|ll Oddzial Chorob Wewnetrznych, Tychy, 43-100, Poland|Samodzielny Zespół Publicznych Zakladów Opieki Zdrowotnej, Wolomin, 05-200, Poland|Arad Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases, Arad, 310158, Romania|Cardiology Private PRactice "Dr. Calin Pop", Baia Mare, 430123, Romania|Private Practice SC "Diabol" SRL, Brasov, 500365, Romania|Private Practice Nicodiab SRL, Bucharest, 010507, Romania|Medical Centre of Diagnosis, Outpatient Treatment and Preventive Medicine, Department of Diabetes, Nutrition and Metabolic Diseases, Bucharest, 011794, Romania|"Prof. Dr. N.C. Paulescu" National Institute of Diabetes, Nutrition and Metabolic Diseases, 1st Clinical Department of Diabetes, Nutrition and Metabolic Diseases, Bucharest, 020475, Romania|"Nicolae Malaxa" Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases, Bucharest, 022441, Romania|Cluj Emergency Clinical County Hospital, Cluj-Napoca, 400006, Romania|Deva County Hospital, Department of Internal Medicine, Deva, 330084, Romania|Private Practice "Morosanu V. Magdalena", Galati, 800371, Romania|Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases, Oradea, 410032, Romania|S.C. Diabmed Dr. Popescu Alexandrina SRL, Ploiesti, 100163, Romania|Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases, Satu Mare, 440055, Romania|Sibiu Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases, Sibiu, 550245, Romania|"Sf. Ioan cel Nou" Suceava Emergencency County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases, Suceava, 720284, Romania|Private Practice "Dr. Gagiu Remus", Targoviste, 130083, Romania|State Institution of Healthcare "Kemerovo Regional Clinical Hospital", Kemerovo, 650066, Russian Federation|State Institution "Endocrinology Scientific Center of the RAMS",, Moscow, 115478, Russian Federation|Medical Institution Public Corporation Polyclinic "Gazprom", Moscow, 117420, Russian Federation|Close Corporation "MEDSI", Moscow, 123056, Russian Federation|State Educational Institution of Continuing Professional Education "Russian Medical Academy of Postgraduate Education of the Federal Agency of Health and Social Development", Chair of Endocrinology and Diabetology, Non-State Institution of Public Hea, Moscow, 125315, Russian Federation|State Institution "Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky, Moscow, 129110, Russian Federation|Limited Liability Company "Clinic of New Medical Technologies", Moscow, 140091, Russian Federation|Regional State Institution of Healthcare "Novosibirsk State Regional Clinical Hospital", Novosibirsk, 630087, Russian Federation|State Institution Scientific Research Institute of Therapy of the Siberian Department of the Russian Academy of Medical Sciences, Novosibirsk, 630089, Russian Federation|Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Federal Agency on High Technology Medical Care, Saint-Petersburg, 194156, Russian Federation|Limited Liability Company "Center "Diabetes", Samara, 443067, Russian Federation|Public Medical Institution "City Outpatient Clinic # 20" of Saratov Administration Healthcare, Saratov, 410018, Russian Federation|State Educational Institution of High Professional Education "Smolensk State Medical Academy of Federal Agency of Healthcare and Social Development, Smolensk, 214018, Russian Federation|State Educational Institution of Higher Professional Education "Medical-Military Academy named after S.M. Kirov, Clinic of Therapy of Postgraduate Education named after N.S. Molchanov, St. Petersburg, 198013, Russian Federation|State Educational Institution of High Professional Education <Siberian State University of Federal Agency of Healthcare and Social Development, Tomsk, 634034, Russian Federation|Municipal Institution of Healthcare Clinical Ambulance Hospital named after N. V. Soloviev, Yaroslavl, 150003, Russian Federation
URL: https://clinicaltrials.gov/show/NCT00455598

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress