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
ConditionType 2 Diabetes Mellitus
InterventionDrug: S-707106
Drug: Placebo
Drug: Metformin, S-707106 plus metformin
Drug: Metformin, placebo plus metformin
PhasePhase 1
SponsorShionogi
Responsible PartyShionogi Inc.
ClinicalTrials.gov IdentifierNCT01154348
First ReceivedJune 25, 2010
Last UpdatedSeptember 13, 2011
Last verifiedSeptember 2011

Tracking Information[ + expand ][ + ]

First Received DateJune 25, 2010
Last Updated DateSeptember 13, 2011
Start DateJune 2010
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measures
  • Safety and pharmacokinetics of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitus [Time Frame: 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] [Designated as safety issue: Yes]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
  • Safety and pharmacokinetics of multiple-dose oral co-administration of S-707106 and metformin in fed state in patients with type 2 diabetes mellitus [Time Frame: 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] [Designated as safety issue: Yes]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
Current Secondary Outcome Measures
  • The effect of multiple doses of S-707106 on pharmacokinetics of metformin [Time Frame: On Day 14 and on day prior to initiation of dosing of S-707106] [Designated as safety issue: No]
  • The effect of multiple doses of metformin on pharmacokinetics of S-707106 [Time Frame: On Day 14] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleStudy 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
Official TitleA 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 TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: 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)
  • Experimental: Washout period, S-707106 tablet
    14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions
  • Placebo Comparator: Washout, placebo
    14-day washout of metformin followed by placebo for S-707106 once daily for 14 days under fed conditions
  • Experimental: Maintenance, S-707106 tablet plus metformin
    14-day maintenance of metformin, followed by S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions
  • Placebo Comparator: Maintenance, placebo plus metformin
    14-day maintenance of metformin, followed by placebo for S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment34
Estimated Completion DateNot Provided
Estimated Primary Completion DateNovember 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01154348
Other Study ID Numbers1011N0913
Has Data Monitoring CommitteeYes
Information Provided ByShionogi Inc.
Study SponsorShionogi
CollaboratorsNot Provided
Investigators Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
Verification DateSeptember 2011

Locations[ + expand ][ + ]

Dennis Ruff, MD
San Antonio, Texas, United States, 78209