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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Dapagliflozin tablet
Sugar pill manufactured to mimic Dapagliflozin 5mg tablet
Children's Hospital Colorado Anschutz Medical Campus
Aurora, Colorado, United States
London Health Sciences Centre Children's Hospital
London, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Measured Glomerular Filtration Rate (mGFR)
Change in mGFR from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Glycated Hemoglobin A1c (HbA1c)
Change in HbA1c from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Adverse events
Rate of adverse events reported from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Diabetes Ketoacidosis (DKA)
Rate of confirmed DKA events from baseline to the end of the 16-week treatment period. All reported and suspected DKA events will be reviewed for confirmation by the study's DKA Adjudication Committee.
Time frame: 16 weeks
Hypoglycemic events
Rate of hypoglycemic events requiring assistance from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Urinary and Genitourinary Tract Infections
Rate of urinary and genitourinary tract infections reported from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Blood Glucose Profile
Change in ambulatory glucose profiles (AGP) from pre-drug initiation to the end of the 16-week treatment period.
Time frame: 16 weeks
Glycemic Variability
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Change in time-in-range (TIR) from baseline to the end of the 16-week treatment period as measured by CGM. TIR is defined as the proportion of time (in %) spent with blood glucose levels between 3.9 and 10.0 mmol/L and will be determined using CGM.
Time frame: 16 weeks
Weight
Change in body weight (in kg) from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Body Mass Index (BMI)
Change in Body Mass Index in (kg/m\<sup\>2\</sup\>) from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks
Maturation
Assessed by Tanner pubertal staging at baseline and the end of the 16-week treatment period.
Time frame: 16 weeks
Total Daily Insulin Dose (TDID)
Change in the total daily dose of insulin (in IU) from baseline to the end of the 16-week treatment period.
Time frame: 16 weeks