Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
February 21, 2025 updated by: Shanghai Changzheng Hospital
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
Shanghai
-
Shanghai, Shanghai, China, 20003
- Shanghai Changzheng Hospital
-
Contact:
- Tuo Li, Dr.
- Phone Number: +8613918507887
- Email: zoe_leeto@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
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.
|
Administered twice-daily for 12 weeks in blinding
Other Names:
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Other Names:
|
|
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.
|
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Other Names:
Administered twice-daily for 12 weeks in blinding
Other Names:
|
|
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.
|
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Other Names:
Administered placebo twice-daily for 12 weeks in blinding
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of treatment emergent adverse events
Time Frame: 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.
|
From baseline week 0 to week 26
|
|
Change in glycated haemoglobin (HbA1c)
Time Frame: 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.
|
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)
Time Frame: 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.
|
From baseline week 0 to week 12 and to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Wei-fen Xie, Prof., Shanghai Changzheng Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
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