New-onset Type 1 Diabetes Mellitus Clinical Trial
Official title:
Inducing Remission in New Onset Type 1 Diabetes Mellitus With Alefacept (Amevive®)
The purpose of this trial is to test whether a drug called alefacept will slow or halt
destruction of the beta cells in the pancreas. If the destruction of the beta cells is
stopped, the patients might be able to produce insulin on their own longer, which could stop
or slow the progression of their type 1 diabetes.
This is a multi-center prospective, placebo-controlled, double-blind and randomized trial to
investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune
destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus
(T1DM).
T1DM is an autoimmune disease that can emerge suddenly, causing dependence on insulin for
life. This means that the immune system (the part of your body that helps fight infections)
mistakenly attacks the cells in the pancreas that produce insulin (beta cells). As beta cells
are destroyed, one's ability to produce insulin is decreased. Insulin helps keep blood
glucose (sugar) levels normal.
For a period right after diagnosis, the pancreas is still able to make small amounts of
insulin. Individuals with diabetes who have the ability to produce some of their own insulin
may be able to achieve better blood sugar control than people who produce no insulin at all.
Based on previous research, doctors think that giving medicines to affect the immune system
soon after diagnosis may stop, delay, or decrease the destruction of beta cells, resulting in
better glucose control. This can help prevent secondary complications of diabetes down the
road.
Research has improved the outlook for T1DM over the last decade. Doctors are investigating,
for example, how to save insulin-producing cells and extend the honeymoon period as long as
possible.
Despite progress towards understanding the science behind T1DM, there remains a significant
need to investigate alternative approaches to this disease in order to bring about long-term
remission. For this reason, scientists are working hard to develop new treatments that can be
given soon after diagnosis to preserve the remaining beta cells.
Currently there is no cure for T1DM; however, with new investigational medications and
innovative clinical research studies, such as T1DAL, a new approach towards managing T1DM may
be on the horizon.
Enrollees will receive weekly intramuscular injections of alefacept or placebo for two 12
week periods, with a 12-week pause between treatment intervals. This schedule or drug dosing
may be altered due to the needs of the subject or at the discretion of the physician
investigator.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02293837 -
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
|
Phase 2 | |
| Terminated |
NCT00515099 -
Study of Antithymocyte Globulin for Treatment of New-onset T1DM
|
Phase 2 |