Open label Randomized Controlled Study comparing the Efficacy of Empagliflozin and Dapagliflozin in Prediabetic patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
研究概览
简要总结
This is an open label randomized controlled clinical trial designed to compare the effects of empagliflozin and dapagliflozin in adults with prediabetes These medicines are SGLT2 inhibitors that lower blood sugar by increasing glucose loss through urine and may also improve insulin sensitivity and body weight
Adults with prediabetes who have not used similar medicines earlier will be enrolled Participants will be randomly assigned into three groups one group will receive empagliflozin plus standard care one group will receive dapagliflozin plus standard care and one group will receive standard care alone control for a fixed study period The main aim is to evaluate which approach is more effective in improving glycaemic control and preventing progression to diabetes
The primary outcome is change in HbA1c from baseline to 6 months HbA1c will be measured at baseline 3 months and 6 months Secondary assessments include changes in body weight lipid profile blood pressure and insulin resistance HOMA IR Safety will be monitored throughout the study by regular follow up visits to record any adverse events
Data will be analysed statistically to identify which group shows better metabolic improvement with fewer adverse effects The findings may help guide early management of prediabetes and delay the onset of diabetes using safe and effective therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients more than 18 years of either gender Patients diagnosed with Prediabetes Fasting plasma glucose 100 to 125mg per dl or HbA1c 5.7 to 6.4 percent Patient willing to give informed consent.
排除标准
- •Patients with Uncontrolled Type 2 Diabetes Patients with eGFR less than 60ml per min per 1.73 meter square Patients with Cardiovascular Event in Past 6 Months Patients with Recurrent Urinary Tract Infection or genital mycotic infection Pregnant or Lactating Women Patients Taking Glucose Lowering drugs in Past 3 months.
研究者
Shoaib Ahmad
Jawaharlal Nehru Medical College Aligarh Muslim University
