Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

Phase 2 Completed 304 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin

Timeline

Start: 2012-02
Primary completion: 2013-01
Completion: 2013-01

Outcome

Met primary endpoint

registry Placebo vs PF-04937319 50 mg; p = 0.0218; LS Mean Difference -0.30 (80% CI -0.48 to -0.11) NCT01517373 ↗

registry Placebo vs PF-04937319 100 mg; p = 0.0006; LS Mean Difference -0.47 (80% CI -0.65 to -0.28) NCT01517373 ↗

Publications

Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glimepiride	Small molecule	6 mg	—
Subject	NERIGLIATIN	Small molecule	10 mg	—
Subject	NERIGLIATIN	Small molecule	50 mg	—
Subject	NERIGLIATIN	Small molecule	100 mg	—