Study to Assess Safety and Pharmacokinetics of Double-Bli... | NCT01154348

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Washout period, S-707106 tablet	Experimental	14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions	Drug: S-707106
Washout, placebo	Placebo Comparator	14-day washout of metformin followed by placebo for S-707106 once daily for 14 days under fed conditions	Drug: Placebo
Maintenance, S-707106 tablet plus metformin	Experimental	14-day maintenance of metformin, followed by S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions	Drug: Metformin, S-707106 plus metformin
Maintenance, placebo plus metformin	Placebo Comparator	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	Drug: Metformin, placebo plus metformin

Name	Type	Description	Arm Group Labels	Other Names
S-707106	Drug	Tablet, taken once daily with morning meal	Washout period, S-707106 tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C000720494	S-707106
D008687	Metformin