Tests LC-Z300-01 in adults with type 2 diabetes
Tests an oral bamboo cane polysaccharide, LC-Z300-01, in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2/3
Where in China
- Shanghai Changzheng HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Changzheng Hospital
- Trial code
- NCT06847178
- Record updated
- 26 February 2025
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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),; Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method,.