Placebo twice daily in blindingLow-dose LC-Z300-01 twice daily in blindingHigh-dose LC-Z300-01 twice daily in blindingHigh-dose LCZ300-1 twice daily in open-label
Placebo twice daily in blinding: Administered placebo twice-daily for 12 weeks in blinding
Low-dose LC-Z300-01 twice daily in blinding: Administered twice-daily for 12 weeks in blinding
High-dose LC-Z300-01 twice daily in blinding: Administered twice-daily for 12 weeks in blinding
High-dose LCZ300-1 twice daily in open-label: Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of treatment emergent adverse events — 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) — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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