Expired Study
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San Antonio, Texas 78209


Purpose:

The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus


Study summary:

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. Specific study withdrawal criteria during washout periods of metformin have been established for loss of glycemic control, i.e., glucose monitoring. Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed


Criteria:

Inclusion Criteria: - Body mass index range (25.0-38 kg/m2) with type 2 diabetes mellitus receiving stable dose of metformin BID for the previous 60 days for glucose control - Patients sterile or agree to use approved method of contraception - No clinically significant abnormal tests - Hemoglobin A1c level ≤10.5% Exclusion Criteria: - History of clinical manifestations of significant metabolic, hepatic, renal, and hematological pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders other than type 2 diabetes mellitus - Uncontrolled diabetes - Exclusionary labs - fasting blood sugar, low hemoglobin, elevated liver function tests, positive result for human immunodeficiency virus, hepatitis B surface antigen, and anti-hepatitis C virus - Low creatinine clearance - History of myocardial infarction within past 90 days or other cardiovascular conditions - Prior exposure to S-707106 - Treatment with investigational study drug within 30 days of study admission day


NCT ID:

NCT01154348


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78209
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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