EUCTR2013-004042-42-GB进行中（未招募）1 期
A study to investigate the potential renoprotective role of sodium-glucose transporter-2 (SGLT-2) antagonist Dapagliflozin in Type 2 diabetic patients with diabetic nephropathy - Dapagliflozin in type 2 diabetic nephropathy (DEER)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Male and female patients aged 35 to 75 years with known diagnosis of type-2 diabetes as per ADA criteria (1) with HbA1c = 7% on monotherapy or combination therapy with approved hypoglycaemic agents (e.g. metformin, sulphonylurea, acarbose, or DPP IV inhibitor, insulin, GLP-1 receptor agonist)
- •-Patients with residual albuminuria (defined as a urine albumin creatinine ratio (ACR) >3 mg/mmol in the preceding 12 months) on maximal tolerated dose of ACE-inhibitor or ARB
- •- preserved renal function [estimated GFR >60 ml/min by 4 variable MDRD equation (23)]
- •- Patients on a stable dose of ACE-inhibitors or ARB in the preceding 3 months.
- •- Written informed consent to participate in the study prior to any study procedures;
- •- Ability to communicate and comply with all study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Patients with impaired renal function (eGFR<60 ml/min);
- •-Patients with recent (6 months) history of cardiovascular or cerebrovascular disease event;
- •-Patients on thiazolidinediones (e.g. Pioglitazone);
- •-Patients who have started drugs which could affect sodium balance (e.g. diuretics, non steroidal anti-inflammatory drugs (NSAID), cyclo-oxygenase (Cox) 2 inhibitors, beta blockers or Calcium channel antagonists) within the previous month;
- •-Patients with uncontrolled hypertension defined as systolic blood pressure and diastolic blood pressure greater than 160 and 100 mmHg respectively;
- •-Pregnancy and lactating females
- •-Pre-menopausal female patients not using contraception;
- •-Patients with very poorly controlled diabetes defined as HbA1c >12%;
- •-Patients with non diabetic renal disease;
- •-Patients with a history of connective tissue disease or inflammatory arthritis;
- •-Recent ( within 3 months) or current use of SGLT2 receptor blocker;
- •-Patients not willing to use appropriate contraception;
- •-Patients on loop diuretics
- •-Recent history of (within 3 years of screening visit) or active malignancy
- •-Patients with New York Heart Association class 3 or 4 cardiac disease
- •-Abnormal Liver function tests defined as ALT or AST levels >3 times the upper limit of normal at screening
- •-History of hereditary glucose-galactose malabsorption or primary renal glucosuria;
- •-History of one or more severe hypoglycaemic episodes within 6 months of screening; (severe hypoglycaemic episodes is as defined by ADA criteria (24).
- •- Previous hypersensitivity to the active substance or to any of the excipients
- •- Patients with an insufficient understanding of the trial
- •- Patients with a history of DKA or at high risk of DKA (T2DM patients with known low C-peptide (<0.25nmol/l), patients with a history of pancreatitis, patients with conditions that lead to restricted food intake or severe dehydration.
研究者
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