drugset / Trial / NCT00976261

A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes

NCT00976261

Phase 1 Completed 72 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of Part A of this study is to test whether repeated doses of the study drug (GSK1614235) are safe and well tolerated (i.e. do not produce unacceptable side effects) and whether we can obtain some preliminary information as to whether it works in lowering blood glucose levels. We will do this by comparing the effect of the study drug with placebo (no drug present) and against a drug (sitagliptin) known to control blood glucose in the treatment of diabetes. The purpose of Part B of this study is to determine the how the timing of dosing, relative to meals, affects the response to study drug.

Timeline

Start
2009-10-17
Primary completion
2010-09-05
Completion
2010-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1614235 Unknown 0.25 mg
Subject GSK1614235 Unknown 1 mg
Subject GSK1614235 Unknown 5 mg
Subject GSK1614235 Unknown 20 mg
Subject GSK1614235 Unknown 40 mg
Subject GSK1614235 Unknown 80 mg
Comparator Sitagliptin Small molecule 100 mg