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

Phase 2

Not yet recruiting

• Conditions: Diabetes; Type 2 Diabetes
• Interventions: Drug: Low-dose LC-Z300-01 twice daily in blinding; Drug: High-dose LC-Z300-01 twice daily in blinding; Dietary Supplement: Placebo twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label

• Registration Number: NCT06847178
• Lead Sponsor: Shanghai Changzheng Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Study Start: 2025-03-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
low-dose LC-Z300-01	Low-dose LC-Z300-01 twice daily in blinding	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.
low-dose LC-Z300-01	High-dose LCZ300-1 twice daily in open-label	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.
high-dose LC-Z300-01	High-dose LC-Z300-01 twice daily in blinding	Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
high-dose LC-Z300-01	High-dose LCZ300-1 twice daily in open-label	Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
Placebo	Placebo twice daily in blinding	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.
Placebo	High-dose LCZ300-1 twice daily in open-label	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.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	From baseline week 0 to week 26	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.
Change in glycated haemoglobin (HbA1c)	From baseline week 0 to week 12 and to week 24	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.

Secondary Outcome Measures

Name	Time	Method
Change in Time in Range (TIR)	From baseline week 0 to week 12 and to week 24	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.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China