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Clinical Trial Details

Trial ID: L6648
Source ID: NCT00976261
Associated Drug: Gsk1614235
Title: A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes
Acronym: SGA112534
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: GSK1614235|DRUG: Sitagliptin|OTHER: Placebo
Outcome Measures: Primary: Part A: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs, 6 days|Part B: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs, 1 day | Secondary: Part A: Pharmacokinetics, 6 days|Part A: Pharmacodynamics, 6 days|Part B: Pharmacokinetics, 1 day|Part B: Pharmacodynamics, 1 day|Part B: 3-O-Methyl-Glucose Kinetics, 1 day
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-10-17
Completion Date: 2010-09-05
Results First Posted:
Last Update Posted: 2017-06-08
Locations: GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, Baton Rouge, Louisiana, 70808, United States|GSK Investigational Site, Cincinnati, Ohio, 45212, United States|GSK Investigational Site, Gières, 38610, France|GSK Investigational Site, Rueil-Malmaison, 92502, France|GSK Investigational Site, Neuss, Nordrhein-Westfalen, 41460, Germany|GSK Investigational Site, Berlin, 14050, Germany|GSK Investigational Site, Hamburg, 22769, Germany|GSK Investigational Site, Cambridge, Cambridgeshire, CB2 2GG, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00976261

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress