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- 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
- 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
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Type 2 Diabetes Mellitus
S-707106 tablet, Placebo, Metformin, S-707106 tablet + Metformin, Metformin, placebo + Metformin
Dennis Ruff, MD
Shionogi USA, Inc.
Published on BioPortfolio: 2014-08-27T03:12:31-0400
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A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.
A biguanide hypoglycemic agent with actions and uses similar to those of METFORMIN. Although it is generally considered to be associated with an unacceptably high incidence of lactic acidosis, often fatal, it is still available in some countries. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290)
An analog of GLUCAGON-LIKE PEPTIDE 1 and agonist of the GLUCAGON-LIKE PEPTIDE 1 RECEPTOR that is used as a HYPOGLYCEMIC AGENT and supplemental therapy in the treatment of DIABETES MELLITUS by patients who do not respond to METFORMIN.
Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)