Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Conditions
Keywords
Empagliflozin, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Diabetic Kidney Disease, Albuminuria
Brief summary
This study was designed to compare empagliflozin and dapagliflozin in reducing protein leakage into the urine in adults with type 2 diabetes and chronic kidney disease. It examined whether the two medicines differed in their effects on urine protein levels. Blood sugar control, kidney function, treatment costs, and side effects were also selected for comparison. The study was planned as a randomized controlled trial at the Nephrology Department of Lahore General Hospital, Lahore, Pakistan. The planned sample comprised 116 men and women aged 20-70 years who had increased urine albumin levels and an estimated glomerular filtration rate, a measure of kidney filtration, above 45 mL/min/1.73 m². Participants were to be assigned by a lottery method to two equal groups of 58 patients. One group was to receive dapagliflozin 5 mg once daily, and the other empagliflozin 10 mg once daily. Assessments were scheduled before treatment and after two and four months. The main assessment was the change in the urine albumin-to-creatinine ratio, which measured the amount of albumin, a blood protein, leaking into the urine. Other assessments included blood tests for kidney function and average blood sugar levels. Treatment costs and side effects, including low blood sugar, urinary tract infections, oral thrush, dehydration, allergic reactions, body pains, and kidney failure, were also included in the follow-up plan. The study aimed to compare the benefits, safety, and costs of these treatments in the selected patients.
Interventions
DRUGDapagliflozin
Dapagliflozin tablet, 5 mg orally once daily for four months.
Empagliflozin tablet, 10 mg orally once daily for four months.
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Months to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 20-70 years. * Male or female patients. * Type 2 diabetes mellitus with chronic kidney disease. * Body mass index ≤45.0 kg/m². * Urinary albumin-to-creatinine ratio \>30 mg/g. * Estimated glomerular filtration rate \>45 mL/min/1.73 m². * Stable dose of an oral antidiabetic medication for at least 4 weeks, or insulin, either alone or with an oral antidiabetic medication, for 8 weeks. * Stable dose of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker for at least 4 weeks.
Exclusion criteria
* Type 1 diabetes mellitus. * Age below 20 years or above 70 years. * Pregnancy. * Hypersensitivity to the study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary albumin-to-creatinine ratio | Baseline, 2 months, and 4 months | Change from baseline in urinary albumin-to-creatinine ratio, measured in mg/g using a spot urine sample. Changes were compared between the dapagliflozin and empagliflozin groups to assess reduction in albuminuria. |
| Change in glycated haemoglobin | Baseline, 2 months, and 4 months | Change from baseline in glycated haemoglobin, measured as a percentage, was compared between the treatment groups to assess glycaemic control. |
| Change in estimated glomerular filtration rate | Baseline, 2 months, and 4 months | Change from baseline in estimated glomerular filtration rate, expressed in mL/min/1.73 m² and calculated using the Modification of Diet in Renal Disease equation, was compared between the treatment groups. |
| Treatment cost per participant | From treatment initiation through 4 months | Treatment expenditure per participant, expressed in Pakistani rupees, was recorded over the four-month treatment period and compared between the treatment groups. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMuneeb Afsar
Lahore General Hospital, Lahore
Outcome results
None listed