DiabetesPhase 2/3NCT06847178
Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
A Phase 2/3 study testing Low-dose LC-Z300-01 twice daily in blinding, High-dose LC-Z300-01 twice daily in blinding and High-dose LCZ300-1 twice daily in open-label in people with Diabetes and Type 2 Diabetes, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 2 Diabetes
- What is being tested?
- Low-dose LC-Z300-01 twice daily in blinding, High-dose LC-Z300-01 twice daily in blinding and High-dose LCZ300-1 twice daily in open-label
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 20003
Tuo Li, Dr., +8613918507887, zoe_leeto@hotmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo twice daily in blinding, Low-dose LC-Z300-01 twice daily in blinding, High-dose LC-Z300-01 twice daily in blinding, High-dose LCZ300-1 twice daily in open-label
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo twice daily in blindingDietary supplement
Also called Double-blind phase （placebo）
Administered placebo twice-daily for 12 weeks in blinding
Low-dose LC-Z300-01 twice daily in blindingDrug
Also called Double-blind phase （LC-Z300-01）
Administered twice-daily for 12 weeks in blinding
High-dose LC-Z300-01 twice daily in blindingDrug
Also called Double-blind phase （LC-Z300-01）
Administered twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-labelDrug
Also called Open-label phase (LC-Z300-01)
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
| Study group | Role | What they receive |
|---|---|---|
| low-dose LC-Z300-01 | Experimental | 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. Receives: Drug: Low-dose LC-Z300-01 twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label |
| high-dose LC-Z300-01 | Experimental | Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01. Receives: Drug: High-dose LC-Z300-01 twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline week 0 to week 12 and to week 24
Secondary outcomes (1)
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.
Measured: From baseline week 0 to week 12 and to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-fen Xie, Prof., Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847178
- Sponsor's protocol ID
- LC-Z300-01
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06847178
- Acronym / sponsor ID
- LC-Z300-01
- Conditions
- Diabetes, Type 2 Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose LC-Z300-01 | Experimental | Drug: Low-dose LC-Z300-01 twice daily in blinding, Drug: High-dose LCZ300-1 twice daily in open-labelExperimental: 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 | Experimental | Drug: High-dose LC-Z300-01 twice daily in blinding, Drug: High-dose LCZ300-1 twice daily in open-labelExperimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo twice daily in blinding, Drug: High-dose LCZ300-1 twice daily in open-labelExperimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo twice daily in blindingAlso: Double-blind phase （placebo）Administered placebo twice-daily for 12 weeks in blinding | Dietary supplement | Placebo |
| Low-dose LC-Z300-01 twice daily in blindingAlso: Double-blind phase （LC-Z300-01）Administered twice-daily for 12 weeks in blinding | Drug | low-dose LC-Z300-01 |
| High-dose LC-Z300-01 twice daily in blindingAlso: Double-blind phase （LC-Z300-01）Administered twice-daily for 12 weeks in blinding | Drug | high-dose LC-Z300-01 |
| High-dose LCZ300-1 twice daily in open-labelAlso: Open-label phase (LC-Z300-01)Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label | Drug | Placebo, high-dose LC-Z300-01, low-dose LC-Z300-01 |
Primary outcome
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.
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.
1 secondary outcome
Change in Time in Range (TIR)
Time frame: From baseline week 0 to week 12 and to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-fen Xie, Prof. study director
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-dose LC-Z300-01 twice daily in blinding, High-dose LC-Z300-01 twice daily in blinding and High-dose LCZ300-1 twice daily in open-label in people with Diabetes and Type 2 Diabetes, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-fen Xie, Prof. (+862181886824, dr.lituo@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (time frame: From baseline week 0 to week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.