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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Dapagliflozin) | Experimental | Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks |
|
| Control (Placebo) | Placebo Comparator | Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 5mg | Drug | Dapagliflozin tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measured Glomerular Filtration Rate (mGFR) | Change in mGFR from baseline to the end of the 16-week treatment period. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin A1c (HbA1c) | Change in HbA1c from baseline to the end of the 16-week treatment period. | 16 weeks |
| Adverse events | Rate of adverse events reported from baseline to the end of the 16-week treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Flow-Mediated Dilation (FMD) | Change in flow mediated dilation using high resolution ultrasound from baseline to the end of the 16-week treatment period. | 16 weeks |
| Pulse Wave Velocity (PWV) | Change in pulse pressure waveforms from baseline to the end of the 16-week treatment period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farid H Mahmud, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| London Health Sciences Centre Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40481206 | Derived | Mahmud FH, Bjornstad P, Clarson C, Clarke A, Anthony SJ, Curtis J, Elia YT, McArthur L, Mertens L, Moineddin R, Kirsch S, Coles N, Maione M, Furman M, Babalola F, Tommerdahl KL, Harrington J, Riddell MC, Prasad P, Huang L, Heerspink HJL, Cherney DZI. Adjunct-to-insulin therapy using SGLT2 inhibitors in youth with type 1 diabetes: a randomized controlled trial. Nat Med. 2025 Jul;31(7):2317-2324. doi: 10.1038/s41591-025-03723-6. Epub 2025 Jun 6. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2026 | May 12, 2026 | 4 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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1:1 ratio for treatment with Dapagliflozin or placebo
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Double-Blinded
| Placebo | Drug | Sugar pill manufactured to mimic Dapagliflozin 5mg tablet |
|
|
| 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. | 16 weeks |
| Hypoglycemic events | Rate of hypoglycemic events requiring assistance from baseline to the end of the 16-week treatment period. | 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. | 16 weeks |
| Blood Glucose Profile | Change in ambulatory glucose profiles (AGP) from pre-drug initiation to the end of the 16-week treatment period. | 16 weeks |
| Glycemic Variability | 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. | 16 weeks |
| Weight | Change in body weight (in kg) from baseline to the end of the 16-week treatment period. | 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. | 16 weeks |
| Maturation | Assessed by Tanner pubertal staging at baseline and the end of the 16-week treatment period. | 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. | 16 weeks |
| 16 weeks |
| Heart Rate Variability (HRV) | Change in heart rate variability from baseline to the end of the 16-week treatment period. | 16 weeks |
| Caloric Intake | Change in daily caloric intake (in kcals) from baseline to the end of the 16-week treatment period. | 16 weeks |
| Macronutrient Intake | Change in daily macronutrient intake (carbohydrates, fat, protein) in grams per kcals from baseline to the end of the 16-week treatment period. | 16 weeks |
| Treatment Satisfaction | Assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), using a standardized scoring system. | 16 weeks |
| Diabetes Management | Assessed using the Diabetes Management Questionnaire (DMQ) using a 20 item questionnaire with standardized scoring. | 16 weeks |
| BOLD MRI | Changes in functional renal imaging | 16 weeks |
| Exercise Session - Blood Glucose Levels | Change in blood glucose levels from pre- to post-exercise from baseline to 4 weeks post-drug initiation. Participants in the optional exercise component will undergo a moderate activity exercise session and will have their blood tested before and at the end of the 60-minute session. | 4 weeks |
| Exercise Session - Blood Glucose Variability | Change in time-in-range (TIR) during a moderate activity exercise session from baseline to 4 weeks post-drug initiation. 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. | 4 weeks |
| London |
| Ontario |
| N6A5W9 |
| Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |