Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes

Naval Military Medical University (Second Military Medical University)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Diabetes; Type 2 Diabetes

Treatments: Drug: High-dose LC-Z300-01 twice daily in blinding; Dietary Supplement: Placebo twice daily in blinding; Drug: Low-dose LC-Z300-01 twice daily in blinding; Drug: High-dose LCZ300-1 twice daily in open-label

Study type: Interventional

Funder types: Other

Identifiers

NCT06847178

LC-Z300-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

low-dose LC-Z300-01

Experimental group

Description:

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.

Treatment:

Drug: High-dose LCZ300-1 twice daily in open-label

Drug: Low-dose LC-Z300-01 twice daily in blinding

high-dose LC-Z300-01

Experimental group

Description:

Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.

Treatment:

Drug: High-dose LCZ300-1 twice daily in open-label

Drug: High-dose LC-Z300-01 twice daily in blinding

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: High-dose LCZ300-1 twice daily in open-label

Dietary Supplement: Placebo twice daily in blinding