NCT04333823: ATTEMPT

Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial

Active, enrolled Phase 3 Last updated 20 November 2023

What this trial tests

Phase 3 trial testing Dapagliflozin 5mg in Diabetes Mellitus, Type 1 in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 December 2020

Primary endpoint
1 May 2024

1 May 2024

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	11 December 2020
Primary completion	1 May 2024
Estimated completion	1 May 2024
Sites	3 locations across United States, Canada

Drugs / interventions tested

• Dapagliflozin 5mg — full drug profile →
• Placebo

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

The Hospital for Sick Children

Who can join

Adults 12 to 18, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Measured Glomerular Filtration Rate (mGFR)
  Time frame: 16 weeks
  Change in mGFR from baseline to the end of the 16-week treatment period.

Sponsor's own description

The ATTEMPT (Adolescent Type 1 diabetes Treatment with SGLT2i for hyperglycEMia \& hyPerfilTration Trial) is a multi-center, double-blinded, randomized, placebo-controlled trial to evaluate the effect of treatment with Dapagliflozin when compared to placebo, in combination with adjustable insulin, on measured GFR in adolescents with T1D 12 to \<19 years of age over a 16-week treatment period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The emergence of obesity in type 1 diabetes.
   Kueh MTW, Chew NWS, Al-Ozairi E, le Roux CW. · · 2024 · cited 62× · PMID 38092958 · DOI 10.1038/s41366-023-01429-8
2. Glomerular hyperfiltration as a therapeutic target for CKD.
   Kanbay M, Copur S, Bakir CN, Covic A, et al · · 2024 · cited 48× · PMID 38308513 · DOI 10.1093/ndt/gfae027
3. SGLT2 Inhibitors in the Management of Type 1 Diabetes (T1D): An Update on Current Evidence and Recommendations.
   Maffei P, Bettini S, Busetto L, Dassie F. · · 2023 · cited 31× · PMID 37964939 · DOI 10.2147/dmso.s240903
4. Diabetic kidney disease in children and adolescents: an update.
   Lopez LN, Wang W, Loomba L, Afkarian M, et al · · 2022 · cited 14× · PMID 34913986 · DOI 10.1007/s00467-021-05347-7
5. CVOT summit report 2024: new cardiovascular, kidney, and metabolic outcomes.
   Schnell O, Almandoz J, Anderson L, Barnard-Kelly K, et al · · 2025 · cited 8× · PMID 40316962 · DOI 10.1186/s12933-025-02700-0
6. Kidney oxygenation, perfusion and blood flow in people with and without type 1 diabetes.
   Laursen JC, Søndergaard-Heinrich N, Haddock B, Rasmussen IKB, et al · · 2022 · cited 8× · PMID 36825032 · DOI 10.1093/ckj/sfac145
7. Kidney hemodynamic effects of sodium-glucose cotransporter 2 inhibitors in diabetes: physiology and clinical implications.
   León-Jiménez D, Sridhar VS, López-Mendoza M, Scholtes RA, et al · · 2025 · cited 7× · PMID 40008354 · DOI 10.1093/ckj/sfae370
8. Adjunct-to-insulin therapy using SGLT2 inhibitors in youth with type 1 diabetes: a randomized controlled trial.
   Mahmud FH, Bjornstad P, Clarson C, Clarke A, et al · · 2025 · cited 5× · PMID 40481206 · DOI 10.1038/s41591-025-03723-6