Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.

"Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days.~1. FBG \>180 mg/dL, no hypoglycemia; glargine increased by 4 IU.~2. FBG \>140 mg/dL, no hypoglycemia; glargine increased by 2 IU.~3. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage.~4. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD.~5. FBG or RBG \< 70 mg/dl, decrease glargine by 8 IU or 20% of TDD.~6. FBG or RBG \< 40 mg/dl, decrease dose of glargine by 30%."

"If the BG levels are \>140 mg/dL, rapid acting insulin analogs will be administered following the supplemental/sliding scale protocol. If a patient is able and expected to eat all or most of his/her meals, supplemental insulin will be administered before each meal and at bedtime following the usual dose of the sliding scale protocol. If a patient is not able to eat, supplemental insulin will be administered every 6 hours following the sensitive dose of the sliding scale. If the BG is 141-180 mg/dL, then 2,3 or 4 units of insulin will be given; for BG 181 - 220 mg/dL; the units of insulin will be 3, 4 or 6; for BG 221 - 260 mg/dL, the units of insulin will be 4,5 or 8; for BG 261 - 300 mg/dL, the units of insulin will be 5, 6 or 10; for BG 301 - 350, the insulin will be 6, 8 or 12 units; for BG 351 - 400 mg/dL, the units of insulin will be 7,10 or 14; for BG\> 400 mg/dL, the insulin will be 8,12 or 16 units."