Dapagliflozin for Type 1 Diabetes in Teens

(ATTEMPT Trial)

Recruiting at 2 trial locations

Overseen by Farid H Mahmud, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: The Hospital for Sick Children

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Farid H Mahmud, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

Adolescents aged 12 to <19 with Type 1 Diabetes for at least a year, taking insulin and having an HbA1c between 7.0-10%. They must understand diabetes management well and agree to use contraception if applicable. Excluded are those with recent severe diabetes complications, certain diets or medical conditions, drug abuse history, or using interfering medications.

Inclusion Criteria

I have been diagnosed with Type 1 Diabetes for over a year.

I use insulin daily through injections or a pump.

I take at least 0.6 Units of insulin per kilogram of my body weight daily.

Exclusion Criteria

You currently abuse alcohol, drugs, or other substances, or have a history of doing so.

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

You are allergic to iohexol.

Treatment Details

Interventions

• Dapagliflozin (SGLT2 Inhibitor)
• Placebo (Drug)

Trial Overview The ATTEMPT trial is testing Dapagliflozin against a placebo in young people with Type 1 Diabetes over a period of 16 weeks. The goal is to see how the drug affects kidney function when added to regular insulin therapy.

Participant Groups

Group I: Intervention (Dapagliflozin) Experimental Treatment 1 Intervention

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

Group II: Control (Placebo) Placebo Group 1 Intervention

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

Dapagliflozin is already approved in Canada for the following indications:

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Dr. Aaron J. Kowalski

Juvenile Diabetes Research Foundation

Chief Executive Officer since 2019

PhD in Microbiology and Molecular Genetics from Rutgers University

Dr. Thomas Danne

Juvenile Diabetes Research Foundation

Chief Medical Officer

MD from Albert Einstein College of Medicine