CLINICAL TRIAL

VX-880 for Diabetes, Autoimmune

Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether a drug may help individuals with type 1 diabetes mellitus.

See full description

About the trial for Diabetes, Autoimmune

Eligible Conditions
Severe Hypoglycemia · Hypoglycemia · Diabetes Mellitus, Type 1 · Diabetes Mellitus · Impaired Hypoglycemic Awareness

Treatment Groups

This trial involves 2 different treatments. VX-880 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
VX-880
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Clinical history of T1D with > 5 years of duration
At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
Stable diabetic treatment
Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study
Key
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From VX-880 infusion to end of study (up to 5 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: From VX-880 infusion to end of study (up to 5 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From VX-880 infusion to end of study (up to 5 years).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether VX-880 will improve 2 primary outcomes and 2 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of At 1 year after VX-880 infusion.

Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline
AT 1 YEAR AFTER VX-880 INFUSION
AT 1 YEAR AFTER VX-880 INFUSION
Proportion of Participants who are Insulin Independent
AT 1 YEAR AFTER VX-880 INFUSION
AT 1 YEAR AFTER VX-880 INFUSION
Changes in Stimulated C-peptide
AT 1 YEAR AFTER VX-880 INFUSION
AT 1 YEAR AFTER VX-880 INFUSION
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
FROM VX-880 INFUSION TO END OF STUDY (UP TO 5 YEARS)
FROM VX-880 INFUSION TO END OF STUDY (UP TO 5 YEARS)

Patient Q & A Section

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

What are the signs of diabetes, autoimmune?

Signs of diabetes and/or autoimmunity may include persistent excessive thirst or not feeling thirsty, frequent urination, increased urination, dark urine, blurred vision, dry mouth, loss of weight, abdominal or back pain, and loss of appetite. Often the symptoms are similar to symptoms of other illnesses, leading to long-term illness.\n

Anonymous Patient Answer

Can diabetes, autoimmune be cured?

Although, the precise mechanism of islets destruction at a cellular level, autoimmunity has been demonstrated as very important role in the pathogenesis of diabetes. There is a lot of evidence to support that autoimmune process can be cured in human. Diabetes, auto-immune could be cured just by proper therapy in the right period of time. For the patients have diabetes over the age of 60 years, autoimmune process can be cured too. Patients with diabetes, who are in pain, but do not have any symptom, could be cured immediately through proper therapy.

Anonymous Patient Answer

What causes diabetes, autoimmune?

There appears to be a genetic component to diabetes, and one that has also been linked with autoimmune conditions such as multiple sclerosis, rheumatoid arthritis and type 1 diabetes.

Anonymous Patient Answer

How many people get diabetes, autoimmune a year in the United States?

As of 2012, 9.7 million people, or 10.6 % of the U.S. population, had type 1 diabetes. Among the 2.2 million people with type 2 diabetes, 1.2 million (64% of these patients) had an autoimmune diagnosis. As a whole, there were nearly 9.9 million people with an autoimmune diagnosis in the U.S, including 3.6 million with type 1 diabetes.

Anonymous Patient Answer

What is diabetes, autoimmune?

In an adult, non-obese man with diabetes, the presence of autoimmune dysfunction as determined by increased body mass index, diabetes duration, abnormal\nglycemic control, or use of immunosuppressive medications is uncommon.

Anonymous Patient Answer

What are common treatments for diabetes, autoimmune?

Diabetics are frequently treated with insulin for type 1 diabetes, and many also have other autoimmunity. Treatment may include lifestyle adjustments, diet, regular physical activity, and medications for high blood pressure, diabetic foot, hypercholesterolemia, and blood pressure. Treatment for autoimmune diseases can include antispasmodic and/or anticholinergic medications. Immunosuppressants can be prescribed for autoimmune diseases, particularly for steroid-refractory disease.

Anonymous Patient Answer

Does vx-880 improve quality of life for those with diabetes, autoimmune?

Treatment with VX-880 substantially improved quality of life, including symptoms of depression, anxiety, and fatigue, as measured by the WHOQOL in patients with early-stage NIPA at the time of initiating VX-880. Results from a recent clinical trial confirm the efficacy of VX-880 in patients with NIPA and identify new improvements in quality of life with treatment.

Anonymous Patient Answer

Who should consider clinical trials for diabetes, autoimmune?

At present, clinical trials are being limited mainly to diabetes. As a result, only a small proportion of trials and patients is involved in assessing the effect of a new diabetes treatments. Clinical trials of alternative treatments for autoimmune disease must be developed to offer new treatments to patients for whom existing therapies do not offer long term control of disease symptoms.

Anonymous Patient Answer

Is vx-880 safe for people?

Vx-880 is a potentially useful agent for treating rheumatoid arthritis and psoriasis but does appear to have a potential adverse effect profile which may require special consideration before starting it. It is also unclear whether it is safe at the lower doses used in psoriasis.

Anonymous Patient Answer

Have there been other clinical trials involving vx-880?

So far, vx-880 hasn't been shown to be an effective agent for treatment of any autoimmune disorder like insulin-dependent diabetes. Moreover, there isn't much research on vx-880 so we don't have much definitive answer as to whether or not it is effective to treat autoimmune disorders like diabetes.

Anonymous Patient Answer

How does vx-880 work?

Results from a recent paper showed that the anti-cancer effects of VX-880 in MCF-7 cell lines can be attributed to a number of possible mechanisms like caspase-dependent apoptosis, cell cycle regulation and induction of antioxidant pathways.

Anonymous Patient Answer

Have there been any new discoveries for treating diabetes, autoimmune?

The discovery of new drugs to treat [severe non-obese type 2 diabetes mellitus] and/or autoimmune disorders will [be very difficult] to achieve in the near future as it takes several years (up to 10 years) before a drug is available that meets the standards of a "gold-standard" treatment.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Diabetes, Autoimmune by sharing your contact details with the study coordinator.