Comparison Between the Efficacy of SGLT2 Inhibitor Therapy Versus ACE Inhibitor in the Treatment of Diabetic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease worldwide. Diabetic kidney disease (DKD) is a clinical diagnosis based upon the presence of reduced glomerular filtration rate (GFR) and/or increased urinary albumin excretion (UACR) in diabetes. The inhibition of the renin-angiotensin system (RAS) has been identified as the cornerstone in the management of DKD for decades. Recently, more evidence supports the use of Sodium-glucose cotransporter 2 inhibitors (SGLT2i) in the treatment of DKD. They were associated with slower progression of renal disease and lower rates of clinically relevant kidney events. Those studies confirmed the SGLT2i efficacy in kidney protection and showed that their addition to angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBS) will be more effective than using ACEi or ARBS alone. It is unclear whether SGLT2i is used as a first-line instead of ACEi or ARB, and to what extent it will be effective in managing DKD compared to the proven effect of ACEi/ARBs alone. This study provides a unique opportunity to address this gap in the literature.

The aim of this study is to compare, head to head, the renal performance of ACEi (standard of care) versus SGLT2 in diabetic patients who have evidence of deteriorating renal function evidenced by either the reduction of e GFR or increased UACR.

Scientific hypotheses:

Null hypothesis:

after one year, the mean change of the e GFR in the enalapril group - Mean change of the e GFR in the empagliflozin group > or = 5 ml/min/1.73m2

Alternative hypothesis:

after one year, the mean change of the e GFR in the enalapril group - Mean change of the e GFR in the empagliflozin group < 5 ml/min/1.73m2

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omar Tarek Elfarargi
• Treatments: Empagliflozin; Enalapril; Enalaprilat

Criteria

Inclusion Criteria:

• Men& women with Type 2 Diabetic patient

• Age 30-65 years old

• UACR above 30mg/g

• eGFR between 30-90 ml/min/1.73m2

• Signed and dated informed consent

• Women must agree to use an effective birth control method if they are heterosexually active during the trial and should have a negative pregnancy test on day 1

Exclusion Criteria:

• T1DM, History of diabetic ketoacidosis, beta-cell or pancreas transplantation, or diabetes secondary to pancreatitis or pancreatectomy

• Age below 30 and above 65 years old

• hyperkalemia (i.e., K above 6)

• ESRF& e GFR less than 30 ml/min/1.73m2

• renal artery stenosis

• type2 DM pregnant woman & gestational DM, breastfeeding

• history of prior amputation or high risk for amputation (including severe peripheral vascular disease, neuropathy, and diabetic foot ulcers)

• History of one or more severe hypoglycemic episodes within 6 months prior to screening Idiopathic or hereditary angioedema

• allergies, or intolerance to trial medications or their excipients