NCT06847178

Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes

A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.

Detailed description

This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes. Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events. The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.

Conditions

• Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo twice daily in blinding	Administered placebo twice-daily for 12 weeks in blinding
DRUG	Low-dose LC-Z300-01 twice daily in blinding	Administered twice-daily for 12 weeks in blinding
DRUG	High-dose LC-Z300-01 twice daily in blinding	Administered twice-daily for 12 weeks in blinding
DRUG	High-dose LCZ300-1 twice daily in open-label	Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study