Last updated on May 2019

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

Are you eligible to participate in this study?

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

  • Conditions: NIDDM
  • Age: Between 30 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Newly diagnosed, drug nave, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM)
  • Hyperfiltration is defined by GFR >135 ml/min1.73m2
  • Normofiltration by a GFR = 90-134 ml/min1.73m2
  • BMI = 20-45 kg/m2
  • HbA1c = 7.5% to 12%
  • Willingness to participate in the 16 week study protocol
  • Hematocrit >34% --BP < 145/90 mmHg

Exclusion Criteria:

  • > 300 mg/day albumin excretion
  • Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy
  • Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment)
  • Proliferative diabetic retinopathy
  • History of cancer or major organ system disease
  • New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3x ULN or total bilirubin > 2.0 mg/dL (34.2 mo/L)
  • Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs
  • Pregnant or nursing mothers
  • Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months
  • Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study
  • Orthostatic hypotension (> 15/10 mmHg decrease upon standing for 3 minutes)
  • Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV
  • Volume depleted patients
  • Estimated glomerular filtration rate <60 mL/min1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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