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Clinical Trial Details

Trial ID: L3297
Source ID: NCT00494663
Associated Drug: Dio-902
Title: A Phase 2b Study of DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo for Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: DIO-902|DRUG: DIO-902|DRUG: DIO-902|DRUG: DIO-902 placebo|DRUG: DIO-902|DRUG: DIO-902|DRUG: DIO-902|DRUG: DIO-902 placebo
Outcome Measures: Primary: 1. The primary efficacy endpoint will be change from baseline to the end of treatment (Study Visit 6, Week 16) in HbA1c, 16 weeks | Secondary: 1. Change from baseline to Week 8 in total and LDL-cholesterol (LDL-C) 2. Change from baseline to the end of treatment (Week 16) in the following : Seated blood pressure (systolic, diastolic and mean arterial pressure) Fasting blood glucose, 16 weeks
Sponsor/Collaborators: Sponsor: DiObex
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2008-12
Results First Posted:
Last Update Posted: 2008-11-13
Locations: Dr. Terence Hart, Muscle Shoals, Alabama, 35662, United States|Genova Research, Tucson, Arizona, 85741, United States|Research Solutions, Jonesboro, Arkansas, 72401, United States|Arkansas Primary Care Clinic, Little Rock, Arkansas, 72211, United States|Advanced Medical Research, Lakewood, California, 90712, United States|Mills-Peninsula Helath Services, San Mateo, California, 94401, United States|Diabetes Research Goup University of Hawaii at Manoa, Honolulu, Hawaii, 96813, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|AHS Oklahoma Physician Group, Tulsa, Oklahoma, 74104, United States|Covance Clinical Research Unit - Dr. Andrew Ahmann, Portland, Oregon, 927239, United States|Covance CRU, Austin, Texas, 78752, United States|Diabetes Glandular and Disease Research Associates, San Antonio, Texas, 78229, United States|Flinders Medical Centre, Adelaide, South Australia, Australia|Lyell McEwin Hospital, North Western Adelaide, South Australia, Australia|ECRU, Box Hill, Melbourne, Victoria, Australia|School of Medicine and Pharmacology, Fremantle, Western Australia, 6160, Australia|Keough Institute, Nedands, Western Australia, 6009, Australia|Endocrinology Research Unit, Herston Road, QLD 4029, Australia|Endocrinology Department, St Leonards, NSW 2065, Australia|Royal Melbourn Hospital, Victoria, Australia|Middlemore Hospital, Otahuhu, Auckland, New Zealand|Lipid and Diabetes Research, Christchurch, New Zealand|Waikaito Hospital, Hamilton, New Zealand|Diabetes Centre, Wellington, New Zealand
URL: https://clinicaltrials.gov/show/NCT00494663

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D438 Levoketoconazole small molecule DB05667 Details