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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes
Started Mar 2025
Shorter than P25 for phase_2 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedFebruary 26, 2025
February 1, 2025
8 months
February 21, 2025
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in Time in Range (TIR)
From baseline week 0 to week 12 and to week 24
Study Arms (3)
low-dose LC-Z300-01
EXPERIMENTALExperimental: 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
EXPERIMENTALExperimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
Placebo
PLACEBO COMPARATORExperimental: 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.
Interventions
Administered placebo twice-daily for 12 weeks in blinding
Administered twice-daily for 12 weeks in blinding
Administered twice-daily for 12 weeks in blinding
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 20003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei-fen Xie, Prof.
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The total duration of the trial for individuals participating in this clinical trial is up to 30 weeks, including: 1. 3-week screening period, 2. 1-week run-in period (may be extended to a maximum of 8 weeks), 3. 12-week double-blind randomized, controlled intervention period, 4. 12-week switching to high-dose conversion, open-label intervention period, 5. 2-week follow-up period. For subjects with an extended run-in period, the trial duration can be up to 37 weeks.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
March 1, 2025
Primary Completion
October 31, 2025
Study Completion
November 30, 2025
Last Updated
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share