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SGLT2 Inhibitor

Dapagliflozin for Type 1 Diabetes in Teens (ATTEMPT Trial)

Phase 3
Waitlist Available
Led By Farid H Mahmud, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type 1 Diabetes, defined by American Diabetes Association Criteria, for at least 12 months.
On Insulin Therapy: Daily injections, to include TID (three times a day), multiple daily dose insulin injection (MDI, > 3 injections daily) or Pump (CSII).
Must not have
Body Mass Index > 99.9th percentile by age and sex.
Type 2 diabetes, Maturity onset Diabetes of Young (MODY) as defined by American Diabetes Association Criteria or pancreatic disorders with resultant impaired pancreatic function.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is testing if a certain type 2 diabetes medication can help improve kidney function in teens with type 1 diabetes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Dapagliflozin may include dehydration, low blood pressure, urinary tract infections, increased urination frequency and risk of diabetic ketoacidosis (a serious complication where the body produces excess blood acids).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 1 Diabetes for over a year.
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I use insulin daily through injections or a pump.
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I take at least 0.6 Units of insulin per kilogram of my body weight daily.
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I, or my legal guardian, can understand and agree to the study's terms.
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I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My BMI is above the 99.9th percentile for my age and sex.
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I have type 2 diabetes, MODY, or a pancreatic disorder affecting its function.
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I am or will be on corticosteroid medication for more than 5 days.
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I am allergic to SGLT2 inhibitors.
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I will not change how I take insulin or switch to a different insulin pump during the study.
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I don't have any untreated or unstable health conditions that could affect the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measured Glomerular Filtration Rate (mGFR)
Secondary study objectives
Adverse events
Blood Glucose Profile
Body Mass Index (BMI)
+8 more
Other study objectives
BOLD MRI
Caloric Intake
Diabetes Management
+7 more

Side effects data

From 2016 Phase 1 trial • 42 Patients • NCT02582840
14%
POLLAKIURIA
7%
THIRST
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin 5mg + Insulin
Dapagliflozin 10 mg + Insulin
Placebo + Insulin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention (Dapagliflozin)Experimental Treatment1 Intervention
Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks
Group II: Control (Placebo)Placebo Group1 Intervention
Dapagliflozin 5mg tablet taken by mouth once daily for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,096 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,973 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
234 Previous Clinical Trials
141,981 Total Patients Enrolled
~20 spots leftby Nov 2025
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