NCT04141241

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Bota Bio Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus With Circulatory Complciation

Interventions

Type	Name	Description
DRUG	Ecklonia cava Phlorotannin	Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.

Timeline

• Start date: 2016-03-04
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2019-10-28
• Last updated: 2019-11-06