Effect of Metformin, Dapagliflozin, Fixed Combination of Metformin and Pioglitazone in Overweighted Patients With Newly Diagnosed Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Insulin resistance
研究概览
简要总结
Although, a number of drugs are promising treatment strategies for insulin resistance, a critical question arises to which drug benefits patients with type 2 diabetes more from reduced insulin resistance and consequent glycemic control. In this study, we aim to evaluate the effect of metformin, dapagliflozin and the fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) on insulin sensitivity and glycemic control in overweight patients with newly diagnosed type 2 diabetes.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in this present study;
- •Regular diet and exercise;
- •Age 18 to 60 years;
- •Screening glycated hemoglobin (HbA1c) > 9.0%;
- •Body mass index (BMI) ≥ 24.0 kg/m2
排除标准
- •Other forms of diabetes;
- •Insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin;
- •Renal dysfunction (estimated glomerular filtration rate < 45 mL/min);
- •Severe liver disease or elevated transaminases (2.5-fold the upper limit);
- •History of alcohol dependence or drug abuse in the past 5 years;
- •Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
- •Acute infection or stress state 1 month prior to this study;
- •Pregnancy or lactation;
- •History of diabetic ketoacidosis (DKA) within the previous year;
- •Psychiatric disease;
- •Other comorbid serious condition including severe heart and pulmonary disease, heart failure of New York Heart Association class IV, and tumors.
研究组 & 干预措施
Metformin
干预措施: Dapagliflozin (Drug)
Metformin
干预措施: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) (Drug)
Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
干预措施: Metformin (Drug)
Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
干预措施: Dapagliflozin (Drug)
Dapagliflozin
干预措施: Metformin (Drug)
Dapagliflozin
干预措施: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) (Drug)
结局指标
主要结局
Insulin resistance
时间窗: week 5
change from baseline insulin resistance at the fifth week
次要结局
未报告次要终点