NCT05760456尚未招募3 期
An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin
Centre of Clinical Pharmacology, Hanoi Medical University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This is an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of enrollment in the study.
- •Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011).
- •Fasting blood glucose ≤ 10.0 mmol/L.
- •No previous treatment with metformin or other antidiabetic drugs.
- •Ability and willingness to provide written informed consent and comply with the protocol's requirements.
- •Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study.
排除标准
- •The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents.
- •Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health.
- •Pregnancy or lactation.
- •Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis.
- •Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.
研究组 & 干预措施
DIDALA
Experimental
DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.
干预措施: DIDALA hard capsules (Drug)
METFORMIN
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
时间窗: 12 weeks
Hemoglobin A1c
次要结局
- Change from Baseline at Week 12 in Fasting Plasma Glucose(12 weeks)
- Safety assessments(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC).Non-Small Cell Lung CancerNCT05240131Galecto Biotech AB88
Unknown
2 期
Evaluate the Efficacy and Safety of ADCV01 as an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) PatientsGBMNCT04115761Ever Supreme Bio Technology Co., Ltd.24
已完成
1 期
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male SubjectsBioavailability StudyNCT03334084argenx40
已完成
4 期
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)HypercholesterolemiaNCT00652327Organon and Co83
已完成
1 期
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy AdultsHealthy VolunteersNCT05976386Sanofi182