Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

Phase 2 Completed 334 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

Timeline

Start: 2007-01-23
Primary completion: 2008-02-14
Completion: 2008-02-14

Outcome

Met primary endpoint

paper RE produced a decreasing dose response in HbA1c at week 12 (p < 0.001), with reductions in HbA1c versus placebo ranging from 0.64 to 1.07% (p < 0.001). PMID 25223369 ↗

registry analysis (superiority or other test); Placebo vs GSK189075 50 mg; p <0.001; Mean Difference (Net) -0.73 (95% CI -1.02 to -0.44); ANCOVA NCT00500331 ↗

Publications

Sykes AP, O'Connor-Semmes R, Dobbins R, Dorey DJ, Lorimer JD, Walker S, Wilkison WO, Kler L. Randomized trial showing efficacy and safety of twice-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):94-7. doi: 10.1111/dom.12391. Epub 2014 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pioglitazone	Small molecule	30 mg	—
Subject	remogliflozin etabonate	Small molecule	50 mg	—
Subject	remogliflozin etabonate	Small molecule	100 mg	—
Subject	remogliflozin etabonate	Small molecule	250 mg	—
Subject	remogliflozin etabonate	Small molecule	500 mg	—
Subject	remogliflozin etabonate	Small molecule	1000 mg	—