Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT02004366
Eligibility Criteria:
Inclusion Criteria:
1. Males or female surgical non-ICU patients ages between18 and 80 years
2. A known history of T2D \> 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
3. Subjects with a BG \>140 mg and \< 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones)
Exclusion Criteria:
1. Age \< 18 or \> 80 years.
2. Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
3. Subjects with a history of type 1 diabetes (suggested by BMI \< 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
4. Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
7. Patients with clinically relevant pancreatic or gallbladder disease.
8. Patients with previous history of pancreatitis
9. Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR \< 30 ml/min).
10. Chronic use of steroid with total daily dose (prednisone equivalent) \>5 mg/day
11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
12. Pregnancy or breast feeding at time of enrollment into the study.
13. Patients who received supplemental sliding scale insulin \>72 hours prior to randomization
14. Patients who received basal insulin \> 48 hours prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02004366
Study Brief:
Protocol Section:
NCT02004366