Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular — PH100_IIa  

Type 2 Diabetes Mellitus With Circulatory Complciation Clinical Trial

Official title: Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-week, Therapeutic Exploratory, Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular Complications

Status Completed

Clinical Trial Summary

This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.

Clinical Trial Description

After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100.

Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus With Circulatory Complciation

• NCT number: NCT04141241
• Study type: Interventional
• Source: Bota Bio Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: March 4, 2016
• Completion date: May 4, 2018