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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
ATTEMPT Trial 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.Check my eligibility
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.See study design
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).
ATTEMPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ATTEMPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measured Glomerular Filtration Rate (mGFR)
Secondary outcome measures
Adverse events
Blood Glucose Profile
Body Mass Index (BMI)
+8 moreOther outcome measures
BOLD MRI
Caloric Intake
Diabetes Management
+7 moreSide effects data
From 2016 Phase 1 trial • 42 Patients • NCT0258284014%
POLLAKIURIA
7%
THIRST
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin 5mg + Insulin
Dapagliflozin 10 mg + Insulin
Placebo + Insulin
ATTEMPT 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
692 Previous Clinical Trials
6,946,500 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,455,057 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,684 Total Patients Enrolled
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