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

Официальное название

A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Placebo twice daily in blinding
  Administered placebo twice-daily for 12 weeks in blinding
• Препарат Low-dose LC-Z300-01 twice daily in blinding
  Administered twice-daily for 12 weeks in blinding
• Препарат High-dose LC-Z300-01 twice daily in blinding
  Administered twice-daily for 12 weeks in blinding
• Препарат High-dose LCZ300-1 twice daily in open-label
  Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label

Первичные конечные точки

• Number of treatment emergent adverse events [Срок оценки: From baseline week 0 to week 26]
• Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline week 0 to week 12 and to week 24]

Вторичные конечные точки (1)

• Change in Time in Range (TIR) [Срок оценки: From baseline week 0 to week 12 and to week 24]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Changzheng Hospital — Шанхай

Идентификаторы

NCT: NCT06847178 · LC-Z300-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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