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OpenTrials
Completed

NCT Number: NCT07591077

SGLT2 Adjunct in T1D

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin (EMPA)

Drug

empagliflozin oral once daily

Placebo

Other

placebo

Primary outcomes

  1. Nephropathy

    Time frame: 6 months

    Change in the UACR after 6 months from baseline.

Secondary outcomes

  1. Glycemic metrics

    Time frame: 6 months

    change in the glycemic metrics after 6 months from baseline

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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