NCT07591077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 9, 2026

Last Update Submit

May 14, 2026

Conditions

Type 1 DiabetesNephropathy, Diabetic

Keywords

SGLT2 inhibitorstype 1 diabetesadolescentsNephropathy

Outcome Measures

Primary Outcomes (1)

  • Nephropathy

    Change in the UACR after 6 months from baseline.

    6 months

Secondary Outcomes (1)

  • Glycemic metrics

    6 months

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin 10 mg once daily

Drug: Empagliflozin (EMPA)

Placebo

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Empagliflozin (EMPA)DRUG

empagliflozin oral once daily

Empagliflozin
PlaceboOTHER

placebo

Placebo

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic NephropathiesKidney Diseases

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and manager of the pediatric diabetes, endocrinology and metabolism unit

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 15, 2026

Study Start

November 20, 2024

Primary Completion

November 20, 2025

Study Completion

February 20, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)