Clinical trial: 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 (NCT02455076)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment