Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT01013766
Brief Summary:
This study is the second administration of GSK1362885 in humans. GSK1362885 is a novel, potent inhibitor of human glycogen phosphorylase (GP) under development for the treatment of type 2 diabetes mellitus (T2DM). This study will investigate the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with Type 2 Diabetes Mellitus.
Detailed Description:
This is the first administration of single doses of GSK1362885 to the target population with T2DM. Based on the mechanism of action which involves reducing hepatic glucose output, it is possible that day time (AM) or night time (PM) dosing of GSK1362885 could produce different plasma glucose lowering effects, acting either on prandial or post-absorptive elevations of HGO. This study is designed to compare glucose profiles following AM and PM doses to determine if there is any advantage to either one. This study will compare glucose profiles following a single dose of GSK1362885 in the morning before breakfast (AM) to a single dose administered at night (PM). These two dosing periods will be randomized and each subject will receive both dosing regimens. A third dosing period (BID) is not randomized, but is included to explore the effects of GSK1362885 on glucose profiles when administered twice daily in a 24 hour timeframe.
Study:
NCT01013766
Study Brief:
Protocol Section:
NCT01013766