This study aims to investigate the potential beneficial effects on the kidney of a new medication called Dapagliflozin in type 2 diabetic patients.

Phase 1

• Conditions: Diabetic Nephropathy; MedDRA version: 20.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-004042-42-GB
• Lead Sponsor: King’s College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified