Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the
immune system does not identify part of the body as belonging to it. The immune system then
destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the
cells in the pancreas that produce insulin. Insulin is the hormone that "unlocks" the cells
of the body. It allows glucose to enter and fuel them. Special cells in the body called
islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The
body's cells literally starve to death. Children are at risk of developing T1DM and the risk
is much higher than other severe, chronic childhood diseases. The only treatments are a
careful diet, planned physical activity, and testing blood sugar levels several times a day.
The patient must also inject insulin each day or use an insulin pump. There is no cure for
T1DM. Insulin injections are considered life support, because going without insulin for just
a few days causes the blood to have too much acid in it and that can lead to death. On the
other hand, taking too much insulin makes blood sugar levels go too low, and if untreated,
can lead to death as well.
DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM
in the first place and it does not go away. The purpose of this study is to see how safe the
study drug is. The study is also going to compare the levels of study drug in the blood and
to measure the effect of the study drug on other substances in the blood that are linked to
type 1 diabetes. These levels will be measured after the study drug is given as an injection
under the skin and an injection into the vein. To date, Lisofylline has been tested when
given as an injection in the vein.
The investigators hypothesize that Lisofylline will be safe when given as an injection under
the skin and in the vein and that levels of study drug will be very similar when given as an
injection under the skin and in the vein.
The investigators also hypothesize that Lisofylline will have a positive effect on the
substances in the blood that are linked to type 1 diabetes.