Phase 3Suspended
Investigational Study of Delayed Release Metformin (DREAM-T2D)
Randomized, Multicenter, Double-blind, Parallel-Group, Placebo & Comparator-Controlled Study to Compare the Glycemic Effects, Safety & Tolerability of Metformin Delayed-Release Tablets in Patients With Type 2 Diabetes Mellitus
- Sponsor
- Anji Pharma (Industry)
- Enrolment
- 675 planned
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Metformin DR; Metformin IR; Metformin DR Placebo; Metformin IR placebo
- Ages
- adults, older adults
- Registry
- NCT04854512
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in HbA1c
History
Study completion
Primary completion
Last registry update
Started
Registered