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Diabetes Mellitus, Type 1Phase 3ATTEMPTNCT04333823

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

A Phase 3 study testing Dapagliflozin 5mg in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Dapagliflozin 5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
11 Dec 2020to May 2024
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Known Hypersensitivity to Iohexol

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Canada2 sites

  • London Health Sciences Centre Children's Hospital

    London, Ontario, N6A5W9

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

United States1 site

  • Children's Hospital Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the detailed 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 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.

Being tested
Dapagliflozin 5mg, Placebo
Keywords
Dapagliflozin, Type 1 Diabetes, Adolescent, Hyperfiltration, Hyperglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 5mgDrug

    Also called FORXIGA 5mg, ATC Code: A10BK01, DIN: 02435462

    Dapagliflozin tablet

  • PlaceboDrug

    Also called Placebo (for Dapagliflozin)

    Sugar pill manufactured to mimic Dapagliflozin 5mg tablet

Study groups in NCT04333823
Study groupRoleWhat they receive
Intervention (Dapagliflozin)ExperimentalDapagliflozin 5mg tablet taken by mouth once daily for 16 weeks
Receives: Drug: Dapagliflozin 5mg
Control (Placebo)Placebo comparatorDapagliflozin 5mg tablet taken by mouth once daily for 16 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measured Glomerular Filtration Rate (mGFR)

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

    Measured: 16 weeks

Secondary outcomes (11)

  1. Glycated Hemoglobin A1c (HbA1c)

    Change in HbA1c from baseline to the end of the 16-week treatment period.

    Measured: 16 weeks

  2. Adverse events

    Rate of adverse events reported from baseline to the end of the 16-week treatment period.

    Measured: 16 weeks

  3. 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.

    Measured: 16 weeks

  4. Hypoglycemic events

    Rate of hypoglycemic events requiring assistance from baseline to the end of the 16-week treatment period.

    Measured: 16 weeks

  5. Urinary and Genitourinary Tract Infections

    Rate of urinary and genitourinary tract infections reported from baseline to the end of the 16-week treatment period.

    Measured: 16 weeks

  6. Blood Glucose Profile

    Change in ambulatory glucose profiles (AGP) from pre-drug initiation to the end of the 16-week treatment period.

    Measured: 16 weeks

  7. 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.

    Measured: 16 weeks

  8. Weight

    Change in body weight (in kg) from baseline to the end of the 16-week treatment period.

    Measured: 16 weeks

  9. 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.

    Measured: 16 weeks

  10. Maturation

    Assessed by Tanner pubertal staging at baseline and the end of the 16-week treatment period.

    Measured: 16 weeks

  11. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start11 Dec 2020
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 ratio for treatment with Dapagliflozin or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333823
Sponsor's protocol ID
CTO1940
Acronym
ATTEMPT
Status last verified
Nov 2023
First submitted
30 Mar 2020
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40481206

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 5mg in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measured Glomerular Filtration Rate (mGFR) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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