Investigational Study of Delayed Release Metformin

Summary

In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B.

Timeline

Start

2021-05-18

Primary completion

2023-12-01

Completion

2024-06-30

Outcome

Outcome not reported

Stopped (Business): “Strategic company decision - not related to a safety concern”

Drugs

Indications