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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 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.

ATTEMPT Trial 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

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 more
Other outcome measures
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

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
686 Previous Clinical Trials
6,944,693 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,341 Previous Clinical Trials
26,452,613 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,684 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of clinical trial been done before?

"Dapagliflozin 5mg has been under clinical trial since 2014, when AstraZeneca first sponsored a study with 700 participants. Since then, it received N/A drug approval and there are currently 67 active trials involving 237 different cities and 50 countries."

Answered by AI

What are the usual indications for Dapagliflozin 5mg?

"Dapagliflozin 5mg is a popular pharmaceutical preparation that not only helps patients with diet, exercise, and inadequate response to monotherapy, but also effectively treats other conditions."

Answered by AI

What have been the most reported side effects of Dapagliflozin 5mg?

"Dapagliflozin 5mg has received a Phase 3 safety rating of 3 from our team at Power. This is based on the available data which suggests that the drug is effective and safe."

Answered by AI

Would I be able to help out with this research by joining the clinical trial?

"Up to 100 adolescents will be enrolled in this study if they have diabetes and an autoimmune disorder. To meet the requirements for this trial, patients must currently use insulin therapy (this includes three daily injections, multiple daily dose injection, or continuous pump), be between 12 and 18 years old, and willing to follow contraception protocol during the study as well as one week after finishing the medication. There is no preference for male or female participants."

Answered by AI

Can new test subjects still enroll in this research project?

"Yes, the information on clinicaltrials.gov indicates that this study is actively looking for participants. The trial was first posted on December 11th 2020 and updated on October 31st 2022. They are hoping to enroll 100 patients from 3 locations."

Answered by AI

How many people can join this clinical trial at maximum capacity?

"From the information available on clinicaltrials.gov, it seems that this study is still enrolling patients. The trial was originally posted on December 11th 2020 and updated as recently as October 31st 2022. They are looking for 100 participants to fill spots at 3 different locations."

Answered by AI

Does age restrict who can and cannot participate in this experiment?

"The age range for this clinical trial are adolescents between 12 to 18 years old."

Answered by AI

What have been the findings of other research studies conducted using Dapagliflozin 5mg?

"The University of Texas Health Science Center at San Antonio first studied dapagliflozin 5mg in 2014. Out of the 18415 completed clinical trials to date, 67 are still ongoing. A majority of these remaining studies are taking place in London, Ontario."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial
Farid Mahmud 2020. "Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04333823.
All > Type 1 Diabetes
~0 spots leftby May 2024
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