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

NCT04333823 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: CTO1940
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Dapagliflozin; Type 1 Diabetes; Adolescent; Hyperfiltration; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Measured Glomerular Filtration Rate (mGFR)

  Change in mGFR from baseline to the end of the 16-week treatment period.

  16 weeks

Secondary Outcomes (11)

• Glycated Hemoglobin A1c (HbA1c)

  16 weeks

• Adverse events

  16 weeks

• Diabetes Ketoacidosis (DKA)

  16 weeks

• Hypoglycemic events

  16 weeks

• Urinary and Genitourinary Tract Infections

  16 weeks

Other Outcomes (10)

• Flow-Mediated Dilation (FMD)

  16 weeks

• Pulse Wave Velocity (PWV)

  16 weeks

• Heart Rate Variability (HRV)

  16 weeks

Study Arms (2)

Intervention (Dapagliflozin)

EXPERIMENTAL

Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks

Drug: Dapagliflozin 5mg

Control (Placebo)

PLACEBO COMPARATOR

Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks

Drug: Placebo

Interventions

Dapagliflozin 5mg DRUG

Dapagliflozin tablet

Also known as: FORXIGA 5mg, ATC Code: A10BK01, DIN: 02435462

Intervention (Dapagliflozin)

Placebo DRUG

Sugar pill manufactured to mimic Dapagliflozin 5mg tablet

Also known as: Placebo (for Dapagliflozin)

Control (Placebo)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Capacity to consent; participants or their parents/legal guardians or responsible representatives must be willing and able to give signed informed consent. Participants without capacity must provide assent where applicable.
• Diagnosis of Type 1 Diabetes, defined by American Diabetes Association Criteria, for at least 12 months.
• Sex: Male and Female.
• Age: 12 years to \<19 years.
• HbA1c: 7.0-10 % at time of screening. Participants with a lower (6.5 to \<7.0%) or a higher HbA1c (\>10.0 to 11.0%) may be considered, based upon investigator discretion, if patient is adherent with study safety criteria, including a good understanding of diabetes management, regular and consistent blood glucose monitoring, appropriate ketone testing and DKA symptom recognition, appropriate adjustment of insulin doses for meals and activity as well as illness.
• On Insulin Therapy: Daily injections, to include TID (three times a day), multiple daily dose insulin injection (MDI, \> 3 injections daily) or Pump (CSII).
• A minimum total daily dose (TDD) of insulin ≥0.6 Units/kilogram/day.
• Females of child bearing potential must be willing to use medically acceptable contraception for the duration of the study and at least one week plus 30 days (one menstrual cycle) post last dose of study drug.

You may not qualify if:

• Pregnancy (positive serum or urine pregnancy test) or breastfeeding.
• Allergies to any member of SGLT2i class of medications.
• Type 2 diabetes, Maturity onset Diabetes of Young (MODY) as defined by American Diabetes Association Criteria or pancreatic disorders with resultant impaired pancreatic function.
• Body Mass Index \> 99.9th percentile by age and sex.
• Presence of severe hypoglycemic event requiring assistance or glucagon rescue medication within 30 days of screening visit.
• Presence of documented Diabetic Ketoacidosis (DKA) within 90 days of screening visit.
• Current and/or anticipated adoption of a carbohydrate-restrictive diet
• Current eating disorder or weight loss \>10% of body weight within 90 days of screening visit.
• Current and or/anticipated systemic corticosteroid therapy for greater than 5 days (not including inhaled, topical, eye or ear drops containing corticosteroids).
• Current or history of alcohol, drug or substance abuse.
• Participation in another drug intervention study within the past 30 days.
• Presence of a clinically untreated or unstable medical condition (including diagnosed Hypertension, SBP\>95%) or laboratory finding that may interfere with any aspect of the study.
• Any concomitant medication known to interfere with the investigational product and/or renal function and/or planned study assessments based on investigators' judgement.
• Unable to adhere with study safety criteria, in the investigator's opinion, including a suboptimal understanding of diabetes management that would include regular and consistent blood glucose monitoring, appropriate ketone testing and DKA symptom recognition, appropriate adjustment of insulin doses for meals and activity as well as illness
• Participants are not allowed to change their insulin administration method (injection to pump or vice versa) throughout the study period, nor change to hybrid or closed loop insulin pumps during the study period.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (3)

Children's Hospital Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

London Health Sciences Centre Children's Hospital

London, Ontario, N6A5W9, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 40481206 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Farid H Mahmud, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 ratio for treatment with Dapagliflozin or placebo

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 3, 2020
• Study Start: December 11, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (2)