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Dapagliflozin + Saxagliptin for Type 2 Diabetes in Youth
Study Summary
This trial is a study to see if two drugs are effective and safe for use in children and adolescents with type 2 diabetes.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- People who have low body fluids.You have anemia, no matter what caused it.You had a serious condition called diabetes ketoacidosis in the last 6 months.You have a history of or currently have pancreatitis.Women who could become pregnant must have a negative pregnancy test within 24 hours before starting the study drug.You have been taking a high dose of corticosteroid medication for a long time before the start of the study.You have been diagnosed with Type 1 diabetes before joining the study.You have an ongoing problem with urine flowing back from your bladder to your kidneys.You have a history of certain blood disorders that cause chronic or recurring breakdown of red blood cells.Your kidneys don't work normally.If your thyroid-stimulating hormone (TSH) level is not normal, we will check your free T4 level.Your HbA1c level is between 6.5% and 10.5%.You have been taking a stable dose of metformin or insulin for at least 8 weeks and have been following a diet and exercise plan.You have health conditions that make it unsafe for you to take the study medications saxagliptin and dapagliflozin, as listed in the information provided to doctors or in the medication packaging.You have a history of kidney disease that is getting worse quickly.You have had cancer within the last 5 years, except for treated basal cell or squamous cell skin cancer.You have blood in your urine that can't be explained by the doctor.If you are taking metformin or insulin for diabetes, your dosage has been stable for at least 8 weeks and you have tried to stop using insulin in the past without success.You are being held against your will for treatment of a mental or physical illness.You currently have an infectious liver disease or have certain antibodies related to liver disease. However, if you only have positive anti-hepatitis B surface antibodies, you may still be included.You have been misusing alcohol or drugs in the past 6 months.Your total bilirubin level in the blood is more than twice the normal level, unless it's only due to Gilbert's syndrome.Your age and ability to have children will be taken into account.The study is looking for a specific group of people to participate.Your liver enzymes (AST or ALT) are more than double the normal level, or you have a significant liver disease.You have been diagnosed with a specific genetic cause of Type 2 diabetes.You have been diagnosed with Type 2 Diabetes Mellitus according to specific guidelines.
- Group 1: Low dose Saxagliptin
- Group 2: Low dose/high dose Dapagliflozin
- Group 3: Low dose Dapagliflozin
- Group 4: Low dose/high dose Saxagliptin
- Group 5: Placebo arm
- 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
How can I become a part of this research project?
"This clinical trial is looking for 256 patients with type 2 diabetes mellitus between the ages of 10 and 18. The following criteria must be met: Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects., Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug., Women must not be breastfeeding., Target Population, Currently on diet and"
Can patients sign up for this experiment right now?
"Unfortunately, this particular trial is not actively recruiting patients at the moment. Although the study was last edited on October 11th, 2022, it originally posted on October 11th, 2017. There are 1525 other studies that are currently looking for participants though."
What stance does the FDA have on Dapagliflozin's dosage levels?
"Since this is a Phase 3 trial, there is available data that supports the efficacy of Low dose/high dose Dapagliflozin. Furthermore, because multiple rounds of data support safety, our team gives it a rating of 3."
Why is Dapagliflozin commonly given in low or high doses?
"When other treatments have failed, Low dose/high dose Dapagliflozin is often used. This medication is also effective in treating patients that suffer from exercise, excercise, and saxagliptin."
Will this trial be accessible to middle-aged individuals?
"This trial is only for children aged 10 to 18. Out of the 2,390 trials hosted on this website, 202 are specifically designed for people in this age group while 1,188 are meant for seniors."
Are there any other investigations that have taken place with Dapagliflozin at different dosage levels?
"There are currently 70 clinical trials underway for Low dose/high dose Dapagliflozin, 11 of which are in Phase 3. The great majority of these studies are taking place in Boston, Massachusetts; however, there are 1083 total locations running these investigations."
How many individuals are being recruited for this clinical trial?
"Unfortunately, this particular trial is not enrolling patients at the moment. The study was initially posted on October 11th, 2017 and was last updated on October 11th, 2020. There are 1455 clinical trials currently recruiting participants with type 2 diabetes mellitus and 70 studies involving high/low doses of Dapagliflozin that are actively admitting patients."
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