At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind (Sponsor Unblinded), Placebo Controlled, Repeat Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin
In Brief
A Phase 2 clinical trial evaluating GSK2330672, Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 16 participants across 1 site.
Detailed Summary
Metformin may have complex interactions in the gut and is generally first line therapy for type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with metformin in subjects with T2DM. The purpose of this study is to investigate the safety and tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin. This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will receive metformin throughout the study
Study Details
Timeline
Interventions
GSK2330672 will be supplied as oral solution, and will be administered BID \[45 mg (2 days repeat dose) and 90 mg (5 days repeat dose) in each period\]
GSK2330672 matching placebo will be supplied as oral solution, and will be administered BID (7 days of dosing in each period)
Metformin 850 mg will be administered BID from Run-in period till Day 7 of period 2