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Study to Assess Safety and Pharmacokinetics (PK) of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

2014-08-27 03:12:31 | BioPortfolio

Summary

Primary Objectives:

- to evaluate the safety and PK of multiple-dose oral administration of S-707106 tablet in fed state in patients with type 2 diabetes mellitus

- to evaluate the safety and PK of multiple-dose oral co-administration of S-707106 and metformin in fed state in patients with type 2 diabetes mellitus

Secondary Objectives:

- to evaluate the effect of multiple doses of S-707106 on PK of metformin

- to evaluate the effect of multiple doses of metformin on PK of S-707106

Description

Safety will be evaluated by monitoring of treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, 12-lead ECGs, 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.

PK assessment of monotherapy cohort versus add-on therapy.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Intervention

S-707106 tablet, Placebo, Metformin, S-707106 tablet + Metformin, Metformin, placebo + Metformin

Location

Dennis Ruff, MD
San Antonio
Texas
United States
78209

Status

Recruiting

Source

Shionogi USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

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