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Clinical Trial Details

Trial ID: L3746
Source ID: NCT01293669
Associated Drug: Tc-6987
Title: Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TC-6987|DRUG: Placebo
Outcome Measures: Primary: Changes in fasting plasma glucose (FPG), The primary efficacy endpoint will be FPG values obtained at Week 4 compared to Day 1 (baseline). This change from baseline will be analyzed using MMRM techniques with an alpha of 0.10 (one-sided), to examine differences between the TC-6987 and placebo treatment cohorts. This change from baseline will be analyzed using the primary efficacy endpoints for the mITT analysis set. The efficacy analyses based on the Per Protocol (PP) analysis set will be considered secondary., Day 1 and Week 4 | Secondary: Change in FPG from Day 1 (Baseline) at each time point, Change in FPG from Day 1 (Baseline) compared to weeks 1 and 4, Day 1, Week 1 and Week 4|Change in FPG and insulin from Day 1 (Baseline) at each time point, Change in FPG and insulin from Day 1 (Baseline) compared to weeks 1 and 4, Day 1, Week 1 and Week 4|Change in AUC FPG from Day 1 (Baseline) and at Week 4, Change in AUC FPG from Day 1 (Baseline) compared to weeks 1 and 4, Day 1 and Week 4|Change in AUC insulin from Day 1 (Baseline) at Week 4, Change in AUC insulin from Day 1 (Baseline) compared to week 4, Day 1 and Week 4
Sponsor/Collaborators: Sponsor: Targacept Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 440
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-01
Completion Date: 2012-01
Results First Posted:
Last Update Posted: 2013-09-13
Locations: Clopton Clinic, Jonesboro, Arkansas, 72401, United States|NCA Medical Center, Mountain Home, Arkansas, 72653, United States|Associated Pharmaceutical Research Center, Buena Park, California, 90620, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Medex Healthcare Research, Inc, St. Louis, Missouri, 63117, United States|Om Medical, Henderson, Nevada, 89052, United States|MEDEX Healthcare Research, Inc, New York, New York, 10004, United States|PMG Research of WS, Winston-Salem, North Carolina, 27103, United States|Rapid Medical Research, Inc., Cleveland, Ohio, 44122, United States|Providence Health Partners - Center for Research, Dayton, Ohio, 45439, United States|Omega Medical Research, Warwick, Rhode Island, 02888, United States|Ellipsis Research, Columbia, South Carolina, 29201, United States|PMG Research of Charleston, Mt. Pleasant, South Carolina, 29464, United States|New Phase Research and Development, Knoxville, Tennessee, 37923, United States|Mercury Clinical Research, Houston, Texas, 77093, United States|Quality Research, Inc., San Antonio, Texas, 78209, United States|Highland Clinical Research, Salt Lake City, Utah, 84124, United States|Strelitz Diabetes Center, Eastern Virginia Medical School, Norfolk, Virginia, 23510, United States
URL: https://clinicaltrials.gov/show/NCT01293669

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress