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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: AstraZeneca
• Treatments: Dapagliflozin; Glipizide; Metformin

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