Type 1 Diabetes Clinical Trial
Official title:
Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study
The purpose of this study is to see if giving the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.
The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar
control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of
long-term health problems. Insulin management is aimed to control blood sugar as near to
normal as safely possible. However, the possibility of low blood sugars still remains. Low
blood sugars the major limiting factor in gaining "tight" control of blood sugar. Insulin
(the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a
key role in keeping this careful balance. There is a lack of insulin and failure of glucagon
to work correctly in diabetes. This leads to high blood sugars right after a meal.
It is very difficult to have normal blood sugars when someone has diabetes. This may be due
to another hormone called amylin. This hormone may be too low in people with Type 1
diabetes. Amylin is made in the pancreas (the part of the body that makes insulin). Amylin
works by lowering blood sugars after a meal. Pramlintide is the name of the study drug. It
is the man-made form of amylin. It is given as a shot (under the skin) like insulin.
Pramlintide has been FDA approved.
Studies in adults have shown that amylin lowers the high levels of glucagon made after a
meal. This results in improved "after meal" high blood sugars and overall blood sugar
control. Currently, the drug is given as a separate shot from insulin. When given as a shot
(one dose shot given all at once) to children and young adults, it seems to cause low blood
sugars right after a meal. The "slowing down" of food digestion may be the cause of the low
blood sugars with pramlintide use. Another possible cause of the low blood sugars may be the
way drug is being given (instant shot versus a slow infusion through a pump).
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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