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)

King’s College London0 sites40 target enrollmentJuly 14, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 14, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\-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

•\-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;