Dapagliflozin add-on to metformin in type 2 diabetes mellitus those who are inadequatively controlled on a stable dose of metformin- In Shahjahanpur district population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To access the effect of Dapagliflozin on:
研究概览
简要总结
Pateints who present to the Varunarjun Medical College and Rohilkhand Hospital with type II DM on Metformin 1-2gm per day will be subjected to further assessment. The selected patients will be evaluated for Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c . Patients with Inadequate Glycemic control will be selected for the study. They will prescribed with DAPAGLIFLOZIN 10mg tablet once daily. The patients will be followed up in OPD every month till 3 months. Blood Pressure, Fasting Blood sugar, 2 hours Post prandial Blood sugar, Body weight will be regularly assessed during routine clinic visits. At the end of 3 months, Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed. Thedifference in all the mentioned parameters will be used to determine theefficacy of DAPAGLIFLOZIN
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with T2DM inadequately controlled with Metformin 1-2 gm per day
- •Those patients who are unable to tolerate further increase in further dose of Metformin
- •Patients aged 30 to 70 years
- •HbA1C 7.0% to 9.0%.
排除标准
- •Patient who are on insulin
- •Patient described any other anti diabetic medication after adding Dapagliflozin to Metformin
- •Patients in which dose of metformin has to be altered
- •Patients with renal insufficiency (GFR lress than 30ml/min/1.73m2)
- •Patients who are known case of urinary tract infection , structural abnormalities of urinary tract.
- •Patients with acute complications of diabetes mellitus
- •Patients with hypersensitivity to drug.
结局指标
主要结局
To access the effect of Dapagliflozin on:
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
1. Glycemic parameters
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
3. Bmi
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
2. Lipid profile
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
4. Blood pressure
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
5. To study the efficacy of Dapagliflozin
时间窗: Selected patients will be evaluated for Blood | Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin | creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body | weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.
次要结局
未报告次要终点