Comparison of Effectiveness and Safety of Dapagliflozin and Empagliflozin in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT)
研究概览
简要总结
Title: Comparison of Effectiveness and Safety of Dapagliflozin and Empagliflozin in Type 2 Diabetes Mellitus
Aim: To study the effectiveness and safety of dapagliflozin and empagliflozin in T2DM
Objective: To compare the effectiveness of empagliflozin in T2DM.
To compare the effectiveness of dapagliflozin in T2DM.
To compare the safety of dapagliflozin in T2DM
To compare the safety of empagliflozin in T2DM
To compare the effectiveness and safety of dapagliflozin and empagliflozin in T2DM
Type of Study: Randomized parallel-group active control trial
Source of data collection: This study will be conducted in the Department of Pharmacology and General Medicine, Teerthanker Mahaveer Medical College and Research Center
All patients diagnosed with T2DM in the Department of General Medicine at Teerthanker Mahaveer Medical College and Research Center
Sample Size: 104
Site of study: TMMC&RC Moradabad, Uttar Pradesh
Inclusion Criteria:
All Patients with Type2 diabetes mellitus as per ADA guidelines
Patients of either gender with age more than 18 years.
Patients giving written informed consent.
Exclusion Criteria:
Pregnant & lactating women.
Patients not complying with study protocol.
Patients with underlying comorbid conditions like recurrent UTI, and chronic renal diseases
Patients with co-morbid conditions like malignancy, psychiatric disorders, substance abuse
Patients with concomitant medications likely to interfere with glycemic control e.g.: Steroids, Beta-blockers, Thiazide Diuretics
Outcome measuring tool
•Effectiveness End Points :
Primary end Points – Change in HbA1c from baseline to end of study.
Secondary end Points – Changes in NT-pro BNP, KFT & FPG from baseline to End of the study.
•Safety End Points:
Incidence of treatment-emergent adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients with Type2 diabetes mellitus as per ADA guidelines Patients of either gender with age more than 18 years.
- •Patients giving written informed consent.
排除标准
- •Pregnant & lactating women.
- •Patients not complying with the study protocol.
- •Patients with underlying comorbid conditions like recurrent UTI, chronic renal diseases.
- •Patients with co-morbid conditions like malignancy, psychiatric disorders, substance abuse Patients with concomitant medications likely to interfere with glycemic control e.g.: Steroids, Beta-blockers, Thiazide Diuretics.
结局指标
主要结局
Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT)
时间窗: Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT) | follow up after 4 weeks and 8 weeks
次要结局
- Adverse drug monitoring using a pre-validated ADR checklist along with spontaneous reporting
研究者
Dr Manu Arya
Teerthanker Mahaveer University Medical College and Research Centre