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GRA (REMD-477) for Type 1 Diabetes
Study Summary
This trial will look at the effects of a new diabetes medication on blood sugar levels, heart health, and ketone production in people with Type 1 diabetes.
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.Side effects data
From 2021 Phase 2 trial • 154 Patients • NCT03117998Trial Design
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Who is running the clinical trial?
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- Your kidney function is normal.I have used diabetes medication other than insulin in the last month.Your HbA1c level is less than or equal to 8.5% at the time of screening.I am between 18 and 65 years old.I weigh at least 50kg.I haven't donated a pint of blood in the last 8 weeks.I am willing and able to follow the study rules and attend all appointments.I have been diagnosed with Type 1 diabetes for over 5 years.You are currently using a continuous glucose monitoring system.I am not pregnant or breastfeeding.I have been diagnosed with anemia that affects my daily life.I have been on a steady insulin pump treatment for at least 8 weeks.I am willing to use contraception during and for 6 months after the study.I have a history of pancreatitis, thyroid cancer, or liver disease.You weigh less than 110 pounds and have a low BMI.I am either post-menopausal, surgically sterile, or willing to use two forms of birth control.
- Group 1: Placebo Group
- Group 2: GRA (REMD-477) Group
- 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 specific qualifications for patient eligibility in this clinical experiment?
"For this medical trial, 30 individuals with diabetes and autoimmune illnesses aged 18 to 65 are being accepted. To qualify for the study applicants must meet a number of criteria, such as having been on an insulin regimen for at least 8 weeks prior to screening, using birth control if applicable, meeting the age range requirement of 18-65 years old, and weighing in at 50 kg or more."
Does this research endeavor include participants that are younger than 45 years old?
"The qualifications for this trial necessitate that potential participants are between the age of 18 to 65. There is a total of 156 studies conducted with patients younger than 18 and another 179 concerning individuals who exceed the upper limit of 65 years old."
How many individuals have registered to participate in this medical experiment?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this trial, originally advertised on July 31st 2021, is actively searching for participants. 30 individuals need to be sourced from a single medical facility."
What safety considerations should be taken into account when utilizing REMD-477?
"REMD-477 is rated a 2 on the safety scale due to its current status as a Phase 2 trial, with evidence indicating some protection from harm but none that suggests efficacy."
Are there current openings to join this experiment?
"Affirmative. The clinicaltrials.gov page for this trial suggests that it is currently recruiting patients, with the original post being from July 31st 2021 and a recent update occurring on November 9th 2022. A total of 30 participants are required to be enrolled at 1 location."
What precedent exists for the therapeutic use of REMD-477?
"Presently, 2 clinical trials are being performed to investigate REMD-477; both of these experiments have not yet entered Phase 3. While the majority of studies occur in San Antonio, Texas, there are also two other locations conducting research on this potential remedy."
Is this experiment a pioneering endeavor in the field?
"The development of REMD-477 began in 2021 and the initial clinical trial was funded by REMD Biotherapeutics, Inc.. Following a successful 30 person Phase 1 assessment, this drug received approval for its second stage of testing. Now two separate trials are ongoing across two cities within one nation."
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