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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00976261

Run by

GlaxoSmithKline

People needed

72

Starts

2009-10-17

Expected to finish

2010-09-05

Last updated by the study team

2017-06-08

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Gières, France
• GSK Investigational Site — Rueil-Malmaison, France
• GSK Investigational Site — Neuss, North Rhine-Westphalia, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Hamburg, Germany
• GSK Investigational Site — Cambridge, Cambridgeshire, United Kingdom

Full record on ClinicalTrials.gov

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