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Semaglutide for Type 1 Diabetes (ADJUST-T1D Trial)
ADJUST-T1D Trial Summary
This trial is testing a new diabetes medication that is given once a week. It is for people who have not been able to control their diabetes well with other treatments.
ADJUST-T1D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADJUST-T1D Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848ADJUST-T1D Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with gastroparesis or a stomach emptying disorder.I have had cancer treatment within the last 5 years.Your HbA1c level is between 7.0% and 10.0% at the time of screening.I am not allergic to insulin, GLP-1RA, or their ingredients.I have not used GLP-1RA or weight loss medications in the last 3 months.I have been using steroidal medication for more than 2 weeks or expect to use it for over 4 weeks.You have a body mass index (BMI) of 30 or higher.I am either 18 years old or younger, or 60 years old or older.I have a history of liver disease.I have had severe low blood sugar in the last 3 months.I use a type of insulin not officially approved with my insulin pump.I have been on insulin for less than a year.I have had pancreatitis before.I was hospitalized for diabetic ketoacidosis within the last 3 months.Your kidney function, measured by eGFR, is below a certain level.I haven't taken any experimental drugs recently.I am planning to have weight loss surgery during the study.You currently have a device to measure ketones in your body.I am willing to take semaglutide once a week.You have a pacemaker, metal implants, or aneurysm clips, but this only excludes you if you need to have an MRI and CT scan.I have been using an FDA-approved automated insulin delivery system for over 3 months.I use insulin injections or inhaled insulin daily.Your blood has high levels of triglycerides when you haven't eaten for a while.I am older than 18 years.I have severe heart failure.I have a glucagon product for severe low blood sugar.I or my family have a history of specific thyroid cancer types.I have been diagnosed with Type 1 Diabetes for over a year.Your HbA1c level is between 7.0% and 10.0%.I have not had a stroke or heart attack in the last 3 months.I am of childbearing age and want to become pregnant.I have type 1 diabetes and am not on any glucose-lowering medications besides insulin.I have been using an FDA-approved automated insulin delivery system for over 3 months.
- Group 1: Semaglutide
- Group 2: Control
- 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
Are there various healthcare facilities administering this trial domestically?
"At present, the medical study is recruiting patients from 4 different clinics. These locations are located in Aurora, Detroit and West Des Moines as well as one other city. Choosing a clinic nearby can reduce your travel burdens if you choose to participate."
To what degree can Semaglutide be detrimental to an individual's health?
"The safety profile of Semaglutide was graded a 2, as it is currently in Phase 2 and there has been some evidence collected on its security but no proof yet of efficacy."
What is the core purpose of this clinical research?
"This clinical trial will measure the efficacy of semaglutide over a 26 week period, with its primary outcome being the proportion of adults with T1D who achieve composite outcomes (CGM-measured time in range >70% and time below range <5%, as well as 5% reduction in body weight) compared to placebo. Secondary metrics include Percent Time Spent In CGM-Measured Glucose Range (TTIR), Change in HbA1c, and Change in Mean Glucose when measured against Intention To Treat Analysis."
Who qualifies to partake in this research endeavor?
"This clinical trial calls for 80 obese individuals between legal adulthood and 60 years old. To qualify, participants must answer 'yes' to the inclusion criteria, maintain a BMI of 30 kg/m2 or higher, provide informed consent prior to any related activities, report having type 1 diabetes for 12 months or more, use FDA-approved hybrid closed-loop systems for at least 3 months lastly have an HbA1c level of over 7% but below 10%."
Are there any opportunities to enroll in this research endeavor at present?
"This research trial, which began on January 1st 2023 and was last updated November 17th 2022 is not currently searching for participants. Nevertheless, there are 2146 other studies that are actively welcoming volunteers at this time."
Is the target group of this research inclusive of elderly people?
"This medical trial solely includes patients aged 18 to 60. Those below the age of consent have access to 410 different trials, while those over 65 are eligible for 1465 studies."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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