REMD-477 for Type 1 Diabetes

UC San Diego Altman Clinical & Translational Research Institute, La Jolla, CA
Type 1 DiabetesREMD-477 - Drug
18 - 65
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: 12-Weeks

Change in Beta-hydroxybutyrate (BHB) Level
Change in Cardiovascular Disease (CVD) Risk Markers.
Change in Free Fatty Acid (FFA) Level
Change in Peripheral Macrovascular Vasodilation
Change in Peripheral Microvascular Vasodilation
Change in mRNA Expression
Metabolic Clearance Rate of Insulin
Rate of Resting Energy Expenditure (REE)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Part B - 35 mg REMD-477
8%Upper respiratory tract infection
4%Diabetic retinopathy
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03117998) in the Part B - 35 mg REMD-477 ARM group. Side effects include: Nausea with 12%, Headache with 8%, Hypoglycaemia with 8%, Dizziness with 8%, Vomiting with 8%.

Trial Design

2 Treatment Groups

GRA (REMD-477) Group
1 of 2
Placebo Group
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: REMD-477 · Has Placebo Group · Phase 2

GRA (REMD-477) Group
Experimental Group · 1 Intervention: REMD-477 · Intervention Types: Drug
Placebo Group
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-weeks

Who is running the clinical trial?

REMD Biotherapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
266 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,051 Previous Clinical Trials
1,827,377 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 0 Total Inclusion Criteria

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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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many individuals have registered to participate in this medical experiment?

"Affirmative. The information hosted on 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are there current openings to join this experiment?

"Affirmative. The 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.