NCT05439473已完成2 期
A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CuraLife
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Effect of treatment with Curalin on the change in plasma HbA1c
研究概览
简要总结
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent is obtained.
- •Adult patients (18-85 years of age) with Type II diabetes mellitus.
- •HbA1c at screening is 8% - 11%.
- •Body mass index (BMI)>
- •Stable body weight (±10%) within the 3 months preceding study entry.
- •Patients were steadily treated with anti-diabetic medications, such as: GLP-1, Glucophage DPP-4 inhibitor or SGLT-2 inhibitor for at least 3 months or more prior to study entry.
- •The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up evaluation as specified in this protocol.
排除标准
- •Patients who have been using Curalin
- •Persons with known sensitivity to any of the components of the Curalin product.
- •The patient has any clinically significant uncontrolled medical condition (treated or untreated).
- •Patients with renal insufficiency (glomerular filtration rate [GFR]≤30 mL/min/1.73m2).
- •Pregnant or lactating women. Women of child bearing potential will be administered a urine pregnancy test at study entry. All study participants will confirm their willingness to use birth control throughout the study.
- •Patients deemed by the Investigator as unable to complete study participation.
- •Patients currently treated with insulin or those that have been treated with insulin for more than 10 days in the 3 months prior to study entry.
- •Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, local, dermal and inhaled steroids, and immunosuppressive or immunomodulating agents for more than a month prior to study entry, or during the study.
- •Patient participated in a clinical study (investigational study drug or study device) within 30 days of the study entry.
- •Life expectancy less than 1 year.
- •History of stroke, transient ischemic attack, or myocardial infarction within six months prior to screening.
- •Patients with uncontrolled hypertension defined as a systolic blood pressure ≥180 mmHg or a diastolic blood pressure ≥100mmHg.
- •Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
- •Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
- •Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1).
- •Laboratory abnormalities at screening including:
- •Potassium > 5.5 mEq/L
- •Sodium ≤ 130 mEq/L
- •Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man.
结局指标
主要结局
Effect of treatment with Curalin on the change in plasma HbA1c
时间窗: 1 month
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c. Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The primary endpoint of the study is HbA1c at 1 month. Blood for HbA1c will be taken at Screening, and M1/Termination of Study. HbA1c level will be ascertained at the local lab, according to the lab's operating procedures Rate of patients that significantly improved their HbA1c levels at least 0.5%.
次要结局
- Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment(1 month)
- Effect of Curalin on Fructosamin based on blood tests(1 month)
- Safety of Curalin as assessed by adverse events(1 month)
研究者
研究点 (1)
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