Role of Exenatide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Exenatide; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.; Each subject received a baseline study with insulin alone
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypoglycemia; Hyperglycemia