A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia (FORWARD)
Brief description of study
In T1D the body’s immune system destroys insulin producing cells called beta cells. This means
the body cannot produce enough insulin to control the amount of sugar in the blood. Beta cells
are located in the pancreas and are part of clusters of cells called pancreatic islets.
These cells produce hormones such as insulin which helps the body to lower blood sugar and
help the body use the blood sugar correctly.
The standard treatment for T1D is insulin given by multiple daily shots or a pump. However, this
treatment does not always control the blood sugar well, with blood sugars being too high or too
low.
Sometimes people with T1D will feel warning signs when their blood sugar is low, such as
sweating and increased heartbeat. This allows them to treat the low blood sugar and the
symptoms right away. Some people do not feel the symptoms when they have low blood sugar
and may therefore delay treating themselves. This condition is called impaired hypoglycemia
awareness. This can lead to extremely low levels of blood sugar and can cause fainting and
seizures and therefore this person will need the help of someone else to treat their low blood
sugar. This is called severe hypoglycemia, and it can be a life-threatening emergency if not
quickly treated.
Detailed description of study
The Study Product we are testing in this research study is called VX-880. This is the first time
that this Study Product has been given to humans. VX-880 is considered investigational.
Investigational means:
- The Study Product is not approved as a marketed product by the United States Food and
Drug Administration (FDA), the European Medicines Agency (EMA) in the European
Union, or any other regulatory (government) authority. - The Study Product is still being tested for safety and effectiveness.
This study is being done to learn more about how safe, tolerable and effective the Study Product
is in participants with T1D with impaired awareness of low blood sugar and who have severe
hypoglycemia. The Study Product is made up of a mixture of cells that are able to make insulin,
as well as other hormones.
The Study Product includes cells that will be transplanted into participants through an infusion
into a large vein that flows blood to the liver. Once infused in the liver, the Study Product may
begin to make and release insulin over time. You may have fewer episodes of severe low blood
sugar, or they may go away completely because of improved control of your blood sugar. You
may also be able to control your blood glucose levels better and to decrease or eliminate your
need for insulin injections.
It is not known if or for how long the Study Product will work. It is not known if the Study
Product will stop working over time, which will cause these benefits to be lost.
Your immune system will try to destroy the Study Product because it is not your own body’s
cells. You will have to take several medications called immunosuppressants to prevent your body
from destroying the Study Product. Immunosuppressants are medicines that weaken the body's
immune system so that the body does not get rid of the cells in the Study Product. These
immunosuppressants are standard medicines approved for this use. You will need to take these
medications for as long as the Study Product is working.
If you are eligible and take part in the study, your participation could last about 5 years after your last infusion of
Study Product. After completing 5 years of follow-up visits, all participants who received Study
Product will be asked to enroll in a 5-year long-term follow-up study.
You will be compensated for your time.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes, T1D, Diabetes, Hypoglycemia
-
Age: 18 years - 65 years
-
Gender: All
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
