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Ertugliflozin for Pediatric Type 2 Diabetes
Study Summary
This trial will study whether ertugliflozin is safe and effective in children with Type 2 Diabetes who are already taking metformin and/or insulin. The goal is to see if ertugliflozin can help lower HbA1C levels more than placebo after 24 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had type 2 diabetes for 2 or more years, or if less, my C-peptide level is above 0.6 ng/mL.I have a genetic form of diabetes or diabetes caused by another condition.I have taken medication like canagliflozin or been in a study for it.I need immediate treatment for high blood sugar or ketones in my urine.I have type 1 diabetes or tested positive for diabetes autoantibodies.I have been on a stable dose of metformin (≥1500 mg/day) for at least 8 weeks, with or without insulin.I have a history of unexplained or chronic pancreatitis.I have had type 2 diabetes for 2 or more years, or if less, my C-peptide level is above 0.6 ng/mL.My BMI is in the top 85% or I was overweight when diagnosed with Type 2 diabetes.I have had severe low blood sugar episodes while using insulin.I have been on a stable dose of metformin (≥1500 mg/day) for at least 8 weeks, with or without insulin.You have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.
- Group 1: Ertugliflozin pidolate 5 mg/5 mg
- Group 2: Ertugliflozin pidolate 5 mg/15 mg
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the goals that this clinical trial is looking to achieve?
"The purpose of this medical intervention, which will be evaluated over the course of 24 weeks, is to change the levels of Hemoglobin A1C in patients. This study also seeks to understand changes in fasting plasma glucose (FPG) and hemoglobin A1c levels over time between those taking ertugliflozin and a placebo group."
Does this research on Insulin build off of other scientific work?
"University of Rome La Sapienza first started studying insulin in 2002. Since then, there have been a total of 19730 clinical trials completed on the topic with 264 more currently active. A large portion of these ongoing studies are based out of Los Angeles, California."
When was Insulin given the green light by the FDA?
"Insulin has been shown to be effective in Phase 3 trials and has received multiple rounds of support for its safety, so it is estimated to be a safe medication."
Is this research project still looking for participants?
"This medical trial is currently looking for participants, as indicated on clinicaltrials.gov. The listing was originally posted on October 8th, 2019 and was last updated on November 4th, 2020."
What medical condition is Insulin routinely given to treat?
"Insulin can help people manage their blood sugar levels after physical activity. It is also used as a treatment for type 1 diabetes mellitus, diabetic ketoacidosis, and diabetes mellitus."
If a patient is 35 years old or younger, do they qualify for this research study?
"This trial is meant for patients aged 10 to 17. Out of the 2,229 clinical trials involving minors, this one falls under the category of 1,364 studies testing treatments on elderly patients."
Does this trial have a presence in more than one hospital within the city limits?
"Children's Hospital - Los Angeles (Site 2201), Barry J. Reiner MD LLC (Site 2204), and London Health Sciences Centre ( Site 0002) are three of the six medical facilities currently running this trial. The other locations are also in 6 different cities."
How many research participants are being enrolled in this clinical trial?
"Yes, the trial is still open and looking for patients. According to the website, this study was first posted on October 8th, 2019 and was last updated November 4th, 2020. They are enrolling 150 people in total from 6 different locations."
Who meets the qualifications to take part in this experiment?
"This study is only recruiting 150 participants, all of whom must be 10-17 years old and have a diagnosis of type 2 diabetes mellitus."
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