Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

Phase 2 Completed 250 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Timeline

Start: 2007-08-17
Primary completion: 2008-06-05
Completion: 2008-06-05

Outcome

Met primary endpoint

paper We observed a statistically significant trend in the RE dose-response relationship for change from baseline in HbA1c at week 12 (p < 0.047). PMID 25238025 ↗

Publications

Sykes AP, Kemp GL, Dobbins R, O'Connor-Semmes R, Almond SR, Wilkison WO, Walker S, Kler L. Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):98-101. doi: 10.1111/dom.12393. Epub 2014 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	—