Type 1 Diabetes Clinical Trial
Official title:
The Role of Exenatide in Type 1 Diabetes Mellitus
The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.
A large study in people with type 1 diabetes (T1DM) 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.
Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar)
play a key role in keeping this careful balance. It is now known that a substance made by the
body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four
ways. First, it helps to stimulate the cells in the pancreas to produce more insulin.
Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and
causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of
food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat
less.
Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is
FDA approved for use in adults.
Study Design: Followed by a baseline study with insulin alone, subjects were randomized to
two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded
randomized controlled manner, along with insulin as a single subcutaneous injection. Studies
were at least 3 weeks apart.
Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's
usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard
liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat),
enriched with 1 g of [13C] glucose within 10 min. Breath samples for 13CO2 analysis were
collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine
were maintained during study.
On the days subjects received the study drug of 1.25 µ,g (~0.02 µ,g/kg) or 2.5 µ,g (~0.04
µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%.
Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat
Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed
intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the
exenatide treated groups vs. insulin monotherapy.
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