Efficacy and safety of Linagliptin and Dapagliflozin versus Vildagliptin and Dapagliflozin in Type 2 Diabetes mellitus: A Randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the effect of combination of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin on HbA1c in T2 DM after 3 months from baseline
研究概览
简要总结
Diabetes Mellitus is a disease that occurs because of excessively high blood glucose. Insulin is released from the pancreas when blood glucose levels rise, such as after a meal. Insulin promotes the removal of glucose from the blood by muscle and fat cells. There are three main types of diabetes mellitus: type 1 (also known as juvenile diabetes) is caused by insufficient insulin production by the pancreas; type 2 (also known as insulin resistance) is triggered by improper cell response to insulin; and the third type is called gestational diabetes, which is caused by elevated blood sugar levels in pregnant women who have never had diabetes before. Type 2 diabetes mellitus is one of the major causes of metabolic disorders in the world and is caused by two main reasons which are defective secretion of insulin from pancreatic beta cells and the failure of insulin-sensitive tissue to respond to insulin. Dapagliflozin is a SGLT2 inhibitor which is approved for the treatment of T2DM in various countries in the world and Linagliptin and vildagliptin are DPP 4 inhibitors which are proven safe and efficacious in various trials. Most of the individuals required multiple drug therapy for treatment of DM. Hence fixed drug combinations are now being prescribed for the management of DM. As per our literature search, there were no studies that did head-to-head comparison of Dapagliflozin plus linagliptin versus Dapagliflozin plus vildagliptin. Hence, we planned to do a head-to-head comparison of Dapagliflozin plus linagliptin versus Dapagliflozin plus vildagliptin in the Indian population
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 65yr
- •Diagnosis of type 2 diabetes mellitus as per ADA criteria.
- •Newly diagnosed Type 2 DM patients.
- •Previously diagnosed DM patient on lifestyle modifications and anti-diabetic drugs.
- •HbA1c more than 7 percentage.
排除标准
- •History of cardiac diseases (NYHA grade 3 – 4) or cardiac anomalies
- •Renal insufficiency.
- •serum creatinine more than or equal to 1.8mg/dl
- •Patients with significant thyroid dysfunction and hepatic impairment (serum bilirubin more than
- •times, AST, ALT, and ALP more than three times the upper limit of normal) 5.Patient have any malignancy 6.Patient have any substance abuse(alcohol/drugs) 7.Pregnant & Lactating Woman 8.Those being treated with any investigational drug within the last 30 days 9.The patient is with severe illness/ infections HbA1c more than 11%.
结局指标
主要结局
To compare the effect of combination of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin on HbA1c in T2 DM after 3 months from baseline
时间窗: 3 months from baseline
次要结局
- To evaluate the effect on fasting blood glucose (FBG) and HOMA index (HOMA-IR and HOMA- beta cell function) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline.(3 months from baseline)
- To evaluate the effect on QOL score (DQOL) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline(3 months from baseline)
- To evaluate the effect on lipid profile parameters of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline.(3 months from baseline.)
- To evaluate the safety of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM over 3 months(3 months from baseline)
研究者
Dr Surjit Singh
All India Institute of Medical Sciences,