Type 2 Diabetes Clinical Trial
Official title:
The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus
The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars
stopped or delayed the occurrence of health problems. As a result of the study, treatment
should try to control blood sugars as near to normal as safely possible.
In people without diabetes, the "after meal" blood sugar level is very carefully controlled
by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone
that raises blood sugar) play a key role in keeping this careful balance. Also, we now know
of 2 new substances made by the body called amylin and GLP-1 that also help with this
careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both
amylin and GLP-1 are abnormal in people with diabetes.
There are two medicines that may help to control after meal blood sugars from going too
high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works
like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that
they work to control blood sugars.
Both medicines help to keep glucagon lower after a meal. They both also help the stomach to
digest food more slowly so the blood sugar does not go up too fast after eating. They also
help to control how much hunger a person may have before meals. This may help a person to
eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make
insulin) make more insulin.
Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs
in children with T2DM.
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