Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Diabetes, Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes
Overview
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.
Interventions
- Dietary supplement Placebo twice daily in blinding
Administered placebo twice-daily for 12 weeks in blinding - Drug Low-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding - Drug High-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding - Drug High-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Primary outcome measures
- Number of treatment emergent adverse events [Time frame: 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]
Secondary outcome measures (1)
- Change in Time in Range (TIR) [Time frame: From baseline week 0 to week 12 and to week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Changzheng Hospital — Shanghai
Identifiers
NCT: NCT06847178 · LC-Z300-01