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Clinical Trial Details

Trial ID: L6944
Source ID: NCT01474083
Associated Drug: Gk1-399 (Formerly Ttp399)
Title: A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: GK1-399 (formerly TTP399)|DRUG: GK1-399 (formerly TTP399)|DRUG: GK1-399 (formerly TTP399)|DRUG: Placebo
Outcome Measures: Primary: Pharmacokinetic parameters of GK1-399 from plasma concentrations, Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration, 52 time points over a 6 week period | Secondary: Pharmacodynamic parameters of plasma glucose, Fasting plasma glucose and postprandial plasma glucose, 52 time points over a 6 week period
Sponsor/Collaborators: Sponsor: vTv Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 248
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-11
Completion Date: 2012-09
Results First Posted:
Last Update Posted: 2013-09-13
Locations: Forest Investigative Site 009, Little Rock, Arkansas, 72211, United States|Forest Investigative Site 006, Chula Vista, California, 91911, United States|Forest Investigative Site 002, Deland, Florida, 32720, United States|Forest Investigative Site 001, Miami, Florida, 33014, United States|Forest Investigative Site 010, Overland Park, Kansas, 66212, United States|Forest Investigative site 011, St. Paul, Minnesota, 55114, United States|Forest Investigative Site 005, Springfield, Missouri, 65802, United States|Forest Investigative Site 003, Neptune, New Jersey, 07753, United States|Forest Investigative Site 008, Willingboro, New Jersey, 08046, United States|Forest Investigative Site 007, New York, New York, 10029, United States|Forest Investigative Site 004, San Antonio,, Texas, 78209, United States
URL: https://clinicaltrials.gov/show/NCT01474083