A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Type 2 Diabetics
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Subjects With Type 2 Diabetes Mellitus|
- Safety and tolerability assessments including adverse events and clinical laboratory tests [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
- Pharmacodynamics following oral administration (glucose, insulin, c-peptide) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters: AUC, Cmax, Tmax, t1/2, tlag, Cl/F, and V/F [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Pharmacodynamics following BID administration (glucose, insulin, c-peptide) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Relationship between pharmacokinetic and pharmacodynamic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Subjects will receive a dose of 100mg in the AM on Day 1, followed by a dose of 100mg in the PM on Day 4, and a dose of 50mg BID on Day 6.
100mg in the AM, 100mg in the PM, 50mg BID
Subjects will receive a dose of 100mg in the PM on Day 1, followed by a dose of 100mg in the AM on Day 4, followed by 50mg BID on Day 6.
100mg in the PM, 100mg in the AM, 50mg BID
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013766
|United States, Arizona|
|GSK Investigational Site|
|Phoenix, Arizona, United States, 85013|
|United States, Minnesota|
|GSK Investigational Site|
|St. Paul, Minnesota, United States, 55114-1067|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|