Last updated on June 2019

The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM | Renal function test
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Female and/or male aged between 18 years and 80 years
  • In the diabetic arms - a diagnosis of T2DM with HbA1c 6.5% (48 mmol/mol) and <10% (<86 mmol/mol); and eGFR (CKD-EPI) between 25 and 50 mL/min/1.73m2 or between >90 and 130 mL/min/1.73m2 for patients aged 59 years or younger, between >85 and 130 mL/min/1.73m2 for patients aged 60 to 69 years, and between >75 and 130 mL/min/1.73m2 for patients aged 70 years or older at the Screening Visit (Visit 1)
  • In the non-diabetic arm, HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI) between 25 and 50 mL/min/1.73m2 at the Screening Visit (Visit 1)
  • Patient specific optimal antihypertensive dose of an angiotensin receptor blocker at least 6 weeks before study treatment
  • In the diabetic arm (Group 2) an appropriate stable dose of metformin, or sulphonylurea, or metformin+sulphonylurea as anti-diabetic therapy for the last 12 weeks before study treatment
  • Stable urinary sodium excretion on 2 successive 24-hr urinary sodium excretion measurements.
  • In the diabetic arm with impaired renal function (Group 1), a stable insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) for the last 12 weeks prior to Visit 4 (Day 1), as judged by the Investigator. Metformin or sulphonylurea, or metformin+sulphonylurea together with insulin would be accepted, but is not mandatory. If used, stable dose of metformin or sulphonylurea, or metformin+sulphonylurea as anti-diabetic therapy for the last 12 weeks prior to Visit 4 (Day 1) is required.

Exclusion Criteria:

  • Diagnosis of Type 1 Diabetes Mellitus
  • Any of the following cardiovascular/vascular diseases within 3 months prior to signing the consent; myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable heart failure, heart failure NYHA Class IV, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia
  • Symptoms/complaints suggestive of established neurogenic bladder and/or incomplete bladder emptying
  • History of bladder cancer, diagnosis of polycystic kidney disease, history or current lupus nephritis or unstable or rapidly progressing renal disease
  • UACR >1000 mg/g at screening
  • Current/chronic use of the following medications: any anti-diabetic medication with the exception of metformin, sulphonylurea, angiotensin converting enzyme inhibitors, insulin (insulin only allowed in Group 1), oral glucocorticoids, non-steroidal anti-inflammatory drugs, immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants and monoamine oxidase inhibitors
  • Receiving immunosuppressive or other immunotherapy for primary or secondary renal disease within 6 months prior to screening
  • Current treatment or treatment within the last 2 weeks prior to screening with diuretics including loop diuretics, thiazides, and mineralocorticoid antagonists

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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