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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Type 2 Diabetes
• Intervention / Treatment: Drug: Low-dose LC-Z300-01 twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label; Drug: High-dose LC-Z300-01 twice daily in blinding; Dietary supplement: Placebo twice daily in blinding

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Wei-fen Xie, Prof.; Phone Number: +862181886824; Email: dr.lituo@smmu.edu.cn
• Study Contact Backup: Name: Tuo Li, Prof.; Phone Number: +86-13918507887; Email: zoe_leeto@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20003
      • Shanghai Changzheng Hospital
      • Contact: Tuo Li, Dr.; Phone Number: +8613918507887; Email: zoe_leeto@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, age reach and over 18 years at the time of signing informed consent,
• Body mass index (BMI) between 18.0 and 35.0 kg/m^2 (both inclusive),
• Type 2 diabetes mellitus (as diagnosed clinically) before screening.
• hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening,
• Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method,
• Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids),
• Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening,
• Presence or history of pancreatitis (acute or chronic) within 180 days before screening,
• Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.

Chronic heart failure classified as being in New York Heart Association Class IV at screening,

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-dose LC-Z300-01; Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 12-weeks of low-dose LC-Z300-01 randamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.	Drug: Low-dose LC-Z300-01 twice daily in blinding; Administered twice-daily for 12 weeks in blinding; Other Names: Double-blind phase （LC-Z300-01）; Drug: High-dose LCZ300-1 twice daily in open-label; Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label; Other Names: Open-label phase (LC-Z300-01)
Experimental: high-dose LC-Z300-01; Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.	Drug: High-dose LCZ300-1 twice daily in open-label; Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label; Other Names: Open-label phase (LC-Z300-01); Drug: High-dose LC-Z300-01 twice daily in blinding; Administered twice-daily for 12 weeks in blinding; Other Names: Double-blind phase （LC-Z300-01）
Placebo Comparator: Placebo; Experimental: placebo + LC-Z300-01 Subjects will receive 12-weeks of placebo radamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.	Drug: High-dose LCZ300-1 twice daily in open-label; Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label; Other Names: Open-label phase (LC-Z300-01); Dietary supplement: Placebo twice daily in blinding; Administered placebo twice-daily for 12 weeks in blinding; Other Names: Double-blind phase （placebo）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events	The differences in adverse events between the patients taking the drug and the placebo group were observed during the double-blind and open-label phases.	From baseline week 0 to week 26
Change in glycated haemoglobin (HbA1c)	During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group.	From baseline week 0 to week 12 and to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time in Range (TIR)	During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group.	From baseline week 0 to week 12 and to week 24

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Investigators: Study Director: Wei-fen Xie, Prof., Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: LC-Z300-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No