CTRI/2023/10/059034尚未招募Phase 3 4
Effect of Dapagliflozin and Metformin Combination on Insulin Resistance and Cardiovascular Disease Risk Factors in Drug Naïve Type II Diabetes Mellitus Patients in a Tertiary Care Hospital: An Open Label Randomized Controlled Trial
S Abissha1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年1月11日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1) TyG index, TG to HDL C ratio from baseline to 12 weeks
研究概览
简要总结
The study hypothesis is to show that Metformin-Dapagliflozin combination is more efficacious than Metformin monotherapy in achieving glycaemic control and reducing insulin resistance and cardiovascular disease risk factors in type II diabetes mellitus patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/female aged 18-60 years 2) Newly diagnosed with type 2 diabetes mellitus patients (FBS>126mg/dl and PPBS>200mg/dl) 3) HbA1c level 7% to 8% 4) Newly diagnosed type II diabetes with or without hypertension and dyslipidemia.
排除标准
- •Diabetes with renal failure 2) Diabetes with liver failure 3) Pregnancy and lactation, psychiatric patients 4) Age above 60 years 5) Patients who are not willing to give informed consent.
结局指标
主要结局
1) TyG index, TG to HDL C ratio from baseline to 12 weeks
时间窗: baseline to 12 weeks
2) Changes in FBS, PPBS & HbA1c, serum uric acid, systolic BP, body mass index, abdominal circumference, waist circumference, neck circumference, waist to hip ratio from baseline to 12 weeks
时间窗: baseline to 12 weeks
次要结局
- Assessing the tolerability & safety of monotherapy and combination therapy based on patient reported outcomes(baseline to 12 weeks)
研究者
研究点 (1)
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