Status:
COMPLETED
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
Lead Sponsor:
Shionogi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01154348
Start Date
June 1 2010
End Date
December 1 2010
Last Update
April 27 2018
Active Locations (1)
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1
Dennis Ruff, MD
San Antonio, Texas, United States, 78209