Comparison Between the Efficacy of SGLT2 Inhibitor Therapy Versus ACE Inhibitor in the Treatment of Diabetic Kidney Disease (SGLT2i VS ACEi)
Diabetic Nephropathy Type 2
About this trial
This is an interventional prevention trial for Diabetic Nephropathy Type 2 focused on measuring diabetic kidney disease (DKD), SGLT2 inhibitors, ACE inhibitors
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Empagliflozin 25 mg arm (SGLT2 inhibitor)
Enalapril 20 mg arm (ACE inhibitor)
empagliflozin 10 mg once daily plus a placebo enalapril 10 mg tab, along with conventional antihypertensive (for hypertension patients) & glycemic control therapies (if present). After four weeks, the dose of empagliflozin will be increased to 25 mg once (with Enalapril 20 mg placebo) daily throughout the study for one year.
enalapril 10 mg tab once daily plus a placebo empagliflozin 10 mg tab, along with conventional antihypertensive (for hypertension patients) & glycemic control therapies (if present). After four weeks, the dose of enalapril will be increased to 20 mg once (with Empagliflozin 25 mg placebo) daily throughout the study for one year.