Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Metformin; Glipizide 5 MG
Intervention description: SGLT2 inhibitor; Oral diabetes medicine that helps control blood sugar levels.; Oral diabetes medicine that helps control blood sugar levels.
Intervention MeSH terms: Metformin; Dapagliflozin; Glipizide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hyperfiltering; Type 2 Diabetes Mellitus

Summary:

      The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or
      without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated
      group will serve as controls for improved glycemic control, since the investigators have
      shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2
             diabetes mellitus (T2DM)

          -  Hyperfiltration is defined by GFR >135 ml/min•1.73m2

          -  Normofiltration by a GFR = 90-134 ml/min•1.73m2

          -  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 µmo/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/min•1.73m2. 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