Clinical trial NCT06847178: Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes
Official title: A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetes
Type 2 Diabetes
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: From baseline week 0 to week 26
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline week 0 to week 12 and to week 24
Secondary outcomes:
measure: Change in Time in Range (TIR)
timeFrame: From baseline week 0 to week 12 and to week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Wei-fen Xie, Prof.
role: STUDY_DIRECTOR
References: