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Clinical Trial Details

Trial ID: L5007
Source ID: NCT00743002
Associated Drug: Tt223 With Metformin And/Or Tzd
Title: A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: TT223 with Metformin and/or TZD|DRUG: Placebo with Metformin and/or TZD
Outcome Measures: Primary: To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg., For the duration of the trial. | Secondary: To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups., For the duration of the trial.|To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing., For the duration of the trial.|To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients., Day 1 and Week 12 of treatment.
Sponsor/Collaborators: Sponsor: OPKO Health, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 87
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date: 2009-12
Results First Posted:
Last Update Posted: 2013-06-21
Locations: Artesia, California, United States|Los Angeles, California, United States|Santa Ana, California, United States|Torrence, California, United States|Walnut Creek, California, United States|Deland, Florida, United States|Bloomingdale, Illinois, United States|Grand Rapids, Michigan, United States|St. Louis, Missouri, United States|Las Vegas, Nevada, United States|Clifton, New Jersey, United States|Asheboro, North Carolina, United States|Wilmington, North Carolina, United States|Bensalem, Pennsylvania, United States|Athens, Tennessee, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|Houston, Texas, United States|Richmond, Texas, United States|San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT00743002

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details