NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 4

Sponsor: The University of Texas Health Science Center at San Antonio

Conditions: Diabetes Mellitus, Type 2

Interventions: Dapagliflozin, Metformin, Glipizide 5 MG

Countries: United States

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 overview

Sex: ALL

Age: 30 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (2)

San Antonio, Texas, United States
San Antonio, Texas, United States