Phase 4
N=72
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02911792 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: GFR (Glomerular Filtration Rate) Change After Treatment — 22; 1; 8; 0 ml/min/1.73m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapagliflozin (Drug); Metformin (Drug); Glipizide 5 MG (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GFR (Glomerular Filtration Rate) Change After Treatment |
22; 1; 8; 0 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02911792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.