The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics in Patients With Type 2 Diabetes and Obesity: A Prospective, Randomized, Open-label, Active Drug Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Extra-cellular volume fraction
研究概览
简要总结
This is a prospective, randomized, open-label, active drug controlled clinical trial that aims to compare the effects of henagliflozin or metformin on myocardial tissue level characteristics in type 2 diabetes patients with obesity. Eligible subjects with type 2 diabetes before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to henagliflozin 10 mg once a day or metformin 1000 mg twice a day and treated for 24 weeks. The study includes five visits.
详细描述
MRI scanning will be assessed at baseline and at the end of the treatment period in order to to assess the cardiac morphology, cardiac function, and myocardial tissue characteristics. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 2 diabetes newly diagnosed based on the WHO (1999) criteria;
- •Hemoglobin A1c levels >=7.0% and <=8.0%;
- •Females or males ≥18 years up to 75 years of age.
排除标准
- •Females or males <18 years.
- •Clinical diagnosis of type 1 diabetes and other types of diabetes.
- •Blood pressure at screening that would require a change in blood pressure treatment over the study period.
- •History of stroke or other clinically significant cerebrovascular disease.
- •Any of the following cardiovascular diseases:
- •Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
- •Unstable heart failure or any heart failure with NYHA class III and IV
- •Significant valvular disease
- •Significant peripheral artery disease
- •Active malignancy requiring treatment at the time of visit
- •Patients with severe hepatic impairment.
- •Unstable or rapidly progressing renal disease.
- •Ongoing treatment with loop diuretics.
- •Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m
- •Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.
研究组 & 干预措施
Henagliflozin
Henagliflozin 10mg qd po
干预措施: Henagliflozin (Drug)
Metformin
Metformin 1000mg bid po
干预措施: Metformin (Drug)
结局指标
主要结局
Extra-cellular volume fraction
时间窗: baseline and week 24
To compare the effects of henagliflozin and metformin on extra-cellular volume fraction
次要结局
- Mean Change in HbA1c Levels(baseline and week 24)
- Mean change in body mass index(baseline and week 24)
- Mean change in blood pressure(baseline and week 24)
- Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(baseline and week 24)
- Native T2 mapping(baseline and week 24)
研究者
Jing Ma
Executive Officer of Endocrinology Department
RenJi Hospital