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Clinical Trial Details

Trial ID: L2442
Source ID: NCT01154348
Associated Drug: S-707106
Title: Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: S-707106|DRUG: Placebo|DRUG: Metformin, S-707106 plus metformin|DRUG: Metformin, placebo plus metformin
Outcome Measures: Primary: Safety and pharmacokinetics of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitus, Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring and physical exams. Pharmacokinetic evaluation of monotherapy cohort versus add-on therapy will be done, Adverse events will be monitored from the time of informed consent through 28 days after the last dose of study treatment. Samples for S-707106 will be collected on Days 1, 7, 10, 12, 13, and 14|Safety and pharmacokinetics of multiple-dose oral co-administration of S-707106 and metformin in fed state in patients with type 2 diabetes mellitus, Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring and physical exams. Pharmacokinetic evalaution of monotherapy cohort versus add-on therapy will be done, Adverse events will be monitored from the time of informed consent through 28 days after the last dose of study treatment. Samples for S-707106 collected on Days 7, 10, 12, 13, and 14. Samples for metformin collected on Days -1, 7, 10, 12, 13, and 14 | Secondary: The effect of multiple doses of S-707106 on pharmacokinetics of metformin, On Day 14 and on day prior to initiation of dosing of S-707106|The effect of multiple doses of metformin on pharmacokinetics of S-707106, On Day 14
Sponsor/Collaborators: Sponsor: Shionogi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2018-04-27
Locations: Dennis Ruff, MD, San Antonio, Texas, 78209, United States
URL: https://clinicaltrials.gov/show/NCT01154348