Comparative Study of DPP-4 Inhibitors and SGLT-2 Inhibitors in Egyptian Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
研究概览
简要总结
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 male/female diabetic patients
- •Age 20-70 years
- •A1C less than 10.5%
排除标准
- •Type 1 diabetes; HbA1c > 10.5%
- •Pregnancy
- •Chronic liver disease
- •Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
- •High bilirubin
- •Albumin < 3.5 g/dl
- •INR >1-2 Diabetic ketoacidosis
- •Urinary tract infection (UTI)
- •Pancreatitis < 6 months prior to enrolment
- •Renal impairment (creatinine clearance ≤50 ml/min)
- •Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
- •Non-compliance with follow-up visits.
研究组 & 干预措施
Sitagliptin 50 mg twice daily
sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.
干预措施: Sitagliptin 50 mg (Drug)
Empagliflozin 12.5 twice daily
Empagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.
干预措施: Empagliflozin 12.5 MG (Drug)
Sitagliptin 50 mg + empagliflozin 12.5 mg
empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks.
干预措施: Sitagliptin 50 mg + Empagliflozin 12.5 MG (Drug)
Empagliflozin 12.5 + sitagliptin 50mg
sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks.
干预措施: Empagliflozin 12.5 MG + Sitagliptin 50 mg (Drug)
结局指标
主要结局
Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
时间窗: After completion of the study (One year anticipated)
The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa. Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl).
次要结局
- The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group(After completion of the study (One year anticipated))
- The decrease in the body weight in patients in sitagliptin group versus empagliflozin group(After completion of the study (One year anticipated))
- The change in lipid profile in patients in sitagliptin group versus empagliflozin group(After completion of the study (One year anticipated))
研究者
Haitham Galal
Teaching assistant (MSC) in Clinical Pharmacy Department
Sadat City University