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 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
The purpose of this study is to try and achieve similar glycemic control in general
 non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in
 combination with basal insulin as compared to treatment with basal bolus insulin alone. The
 association between hyperglycemia and poor clinical outcomes in patients with diabetes is
 well established. Previous studies have shown that basal bolus insulin regimens improve
 glycemic control and reduce the rate of hospital complications compared to sliding scale
 regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators
 will compare the efficacy and safety of exenatide alone or in combination with basal insulin
 to control high blood glucose levels resulting in a lower risk of hypoglycemia.
The association between hyperglycemia and poor clinical outcomes in patients with diabetes is
 well established. Data from previous trials in hospitalized patients have shown a strong
 association between hyperglycemia and poor clinical outcomes, such as mortality, morbidity,
 length of stay (LOS), infections and overall complications. Basal bolus insulin regimens
 improve glycemic control and reduce the rate of hospital complications compared to sliding
 scale regular insulin (SSRI). However, the use of basal bolus is labor intensive, requiring
 multiple daily insulin injections, and has a significant risk of hypoglycemia. The
 investigators will study if treatment with exenatide alone or in combination with basal
 insulin will result in similar glycemic control and a lower frequency of hypoglycemia than
 treatment with basal bolus in general non-Intensive Care Unit (non-ICU) patients with Type 2
 Diabetes.
Inclusion Criteria:

 1. A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic
 drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or
 metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5
 unit/kg/day.

 2. Males or females between the ages of 18 and 80 years discharged after hospital
 admission from general medicine and surgery services (non-Intensive Care Unit
 setting).

 3. Subjects with an admission / randomization BG < 400 mg/dL without laboratory evidence
 of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary
 ketones).

 4. Admission HbA1c between 7% and 10%

 5. BMI range: > 25 Kg/m^2 and < 45 Kg/m^2

 Exclusion Criteria:

 1. Age < 18 or > 80 years

 2. Subjects with increased blood glucose (BG) concentration, but without a history of
 diabetes (stress hyperglycemia)

 3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m^2 requiring
 insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar
 hyperglycemic state, or ketonuria).

 4. Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3
 months prior to admission.

 5. Patients that required ICU care during the hospital admission.

 6. Recurrent severe hypoglycemia or hypoglycemic unawareness.

 7. Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or
 those expected to require gastrointestinal suction.

 8. Patients with clinically relevant pancreatic or gallbladder disease.

 9. Patients with unstable or rapidly progressing renal disease or severe renal impairment
 (creatinine clearance < 30 ml/min)

 10. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage
 liver disease),

 11. History of hypersensitivity to exenatide

 12. Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5
 mg/day), parenteral nutrition and immunosuppressive treatment.

 13. Patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks
 per day) or drug abuse within 3 months prior to admission.

 14. Mental condition rendering the subject unable to understand the nature, scope, and
 possible consequences of the study.

 15. Female subjects who are pregnant or breast feeding at time of enrollment into the
 study.