drugset / Trial / NCT00672386

A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

NCT00672386 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin. The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status. Additional measures include fasting glucose, and lipid levels, and body weight. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.

Timeline

Start
2007-12
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject USISTAPIDE Small molecule 5 mg —
Subject USISTAPIDE Small molecule 10 mg —
Subject USISTAPIDE Small molecule 15 mg —
Background Metformin Small molecule — —