The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 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.

Inclusion Criteria:

- Children with Type 2 Diabetes,

- Between the ages of 12-21 years,

- Tanner stage 4-5 for pubertal development,

- Menstruating females must have a negative urine pregnancy test for inclusion,

- Must have T2DM for at least 6 months,

- History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell
antibodies,

- HbA1c < 8.5% and on a stable dose of an oral hypoglycemic agent (with or without
insulin) over the last 2 months, or well controlled on diet.

Exclusion Criteria:

- A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory
bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia,
cholelithiasis etc),

- BMI> 40 kg/m2,

- Weight of < 60 kg,

- Female with menstrual irregularities,

- Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),

- Evidence or history of chemical abuse,

- Anemia (age specific normal range for hemoglobin will be used),

- Elevated liver enzymes (defined as more than 3 times the upper limit of the normal
range for age),

- Elevated BUN or creatinine (defined as more than 3 times the upper limit of the
normal range for age),

- Use of medications that may increase the blood sugars and admission to the hospital
for diabetes related problems over the last 6 months.