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
Overview[ - collapse ][ - ]
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 |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: S-707106 Drug: Placebo Drug: Metformin, S-707106 plus metformin Drug: Metformin, placebo plus metformin |
Phase | Phase 1 |
Sponsor | Shionogi |
Responsible Party | Shionogi Inc. |
ClinicalTrials.gov Identifier | NCT01154348 |
First Received | June 25, 2010 |
Last Updated | September 13, 2011 |
Last verified | September 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | June 25, 2010 |
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Last Updated Date | September 13, 2011 |
Start Date | June 2010 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief 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 |
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Official Title | A Phase 1b, Randomized, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus |
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. 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 |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: S-707106 Tablet, taken once daily with morning meal Drug: Placebo Placebo tablet, taken once daily with morning meal Drug: Metformin, S-707106 plus metformin Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily Drug: Metformin, placebo plus metformin Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 34 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | November 2010 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01154348 |
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Other Study ID Numbers | 1011N0913 |
Has Data Monitoring Committee | Yes |
Information Provided By | Shionogi Inc. |
Study Sponsor | Shionogi |
Collaborators | Not Provided |
Investigators | Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi |
Verification Date | September 2011 |
Locations[ + expand ][ + ]
Dennis Ruff, MD | San Antonio, Texas, United States, 78209 |
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