A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263

Phase 2 Completed 66 enrolled GlaxoSmithKline

RandomizedSingle-groupSingle-blindTreatment

Summary

A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263

Timeline

Start: 2009-11-23
Primary completion: 2010-04-12
Completion: 2010-04-12

Outcome

Missed primary endpoint

paper We conclude that GSK263 did not improve glucose control in type 2 diabetics, but it had profound effects on circulating PYY. PMID 24699248 ↗

registry Placebo vs GSK1292263 600 mg; Mean Difference (Net) 0.748 (95% CI -0.02 to 1.52) NCT01128621 ↗

Publications

Nunez DJ, Bush MA, Collins DA, McMullen SL, Gillmor D, Apseloff G, Atiee G, Corsino L, Morrow L, Feldman PL. Gut hormone pharmacology of a novel GPR119 agonist (GSK1292263), metformin, and sitagliptin in type 2 diabetes mellitus: results from two randomized studies. PLoS One. 2014 Apr 3;9(4):e92494. doi: 10.1371/journal.pone.0092494. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK1292263	Small molecule	—	Oral
Comparator	Sitagliptin	Small molecule	50 mg	—