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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
The Hospital for Sick Children
Study ID
NCT04333823
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 5mg — DRUG
    Dapagliflozin tablet
  • Placebo — DRUG
    Sugar pill manufactured to mimic Dapagliflozin 5mg tablet

Study Details

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.

Key Dates

Start date
Dec 11, 2020
Status verified
Nov 2023
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention (Dapagliflozin)
    Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks
  • Placebo Comparator: Control (Placebo)
    Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks

Primary Outcome Measure

Measured Glomerular Filtration Rate (mGFR) [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado Anschutz Medical CampusAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Children's Hospital Colorado Anschutz Medical Campus· Aurora, CO

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