SGLT2 Adjunct in T1D

Ain Shams University86 enrolled

Overview

Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus

Eighty six adolescents with T1D nephropathy according to the ISDAD 2022 guidelines were assigned into two equal groups randomly, one received empagliflozin initiated at 10 mg once daily in addition to their insulin therapy and the other received insulin therapy and placebo. Blood pressure percentiles, urine output, fasting lipids profile, HbA1C and CGM metrics were assessed at baseline, 3 and 6 months of therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Nephropathy, Diabetic

Interventions

Empagliflozin (EMPA)DRUG

empagliflozin oral once daily

PlaceboOTHER

placebo

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with T1DM according to the international society of pediatric and adolescent diabetes (ISPAD). (Couper et al., ISPAD 2022). * Age 10- 18 years old. * Diabetic nephropathy according to ISPAD. (Couper et al., ISPAD 2022). * eGFR \> 30 ml/min per 1.73 m2 Exclusion Criteria: * Patient with other types of diabetes e.g. T2DM, maturity onset diabetes of the young (MODY). * Presence of contraindication for empagliflozin e.g. History of serious hypersensitivity reaction to empagliflozin, end-stage renal disease, or dialysis. * Other types of nephropathy.

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Nephropathy

Change in the UACR after 6 months from baseline.

Time frame: 6 months

Secondary Outcomes

Glycemic metrics

change in the glycemic metrics after 6 months from baseline

Time frame: 6 months

Data from ClinicalTrials.gov

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