Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetes Mellitus - Type 1
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1 ratio for treatment with Dapagliflozin or placeboMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-BlindedPrimary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 18 years
Gender
Both males and females

Description

The ATTEMPT (Adolescent Type 1 diabetes Treatment with SGLT2i for hyperglycEMia & hyPerfilTration Trial) is designed to evaluate the impact of Dapagliflozin versus placebo in combination with insulin therapy. This trial will assess detailed renal mechanistic evaluations, with direct measurement of G...

The ATTEMPT (Adolescent Type 1 diabetes Treatment with SGLT2i for hyperglycEMia & hyPerfilTration Trial) is designed to evaluate the impact of Dapagliflozin versus placebo in combination with insulin therapy. This trial will assess detailed renal mechanistic evaluations, with direct measurement of GFR, to understand the important physiologic impacts of SGLT2 inhibition on the early onset manifestations and progression of diabetes complications within this age group. Fundamentally, the ATTEMPT trial will provide essential information in establishing a framework for this young cohort to evaluate key physiologic, mechanistic and metabolic outcomes.

Tracking Information

NCT #
NCT04333823
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Farid H Mahmud, MD The Hospital for Sick Children