Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- High-density lipoprotein (HDL) levels
研究概览
简要总结
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
open labelled, multi-centric, parallel, randomized control trial
In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy & safety parameters to be measured at both the baseline and 24-week visits.
详细描述
Background:
Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.
Objective:
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
Methods:
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
- •Uncontrolled type 2 diabetes mellitus (> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
- •BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2
排除标准
- •Pregnant female or female patients planning to conceive during the study period were excluded from this study.
- •"Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
研究组 & 干预措施
Empagliflozin
干预措施: Empagliflozin (Drug)
Vildagliptin
干预措施: Vildagliptin (Drug)
结局指标
主要结局
High-density lipoprotein (HDL) levels
时间窗: 24 weeks
Systolic blood pressure
时间窗: 24 weeks
Fasting blood sugars
时间窗: 24 weeks
Bodyweight
时间窗: 24 weeks
Serum creatinine
时间窗: 24 weeks
Serum glutamic-pyruvic transaminase (SGPT)
时间窗: 24 weeks
Low-density lipoprotein cholesterol
时间窗: 24 weeks
Total cholesterols
时间窗: 24 weeks
Serum triglycerides
时间窗: 24 weeks
Glycosylated hemoglobin A1c (HbA1c)
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Jaffer Bin Baqar
Dr. Asima Niazi
Dow University of Health Sciences