Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial
Last updated on July 2021Recruitment
- 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