Linagliptin Inpatient Trial

Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily
glucose concentration and frequency of hypoglycemic events, is different between treatment
with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before
meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog
before meals in general surgery patients with T2D.

Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in
controlling BG after discharge in patients with T2D. Patients who participate in the
in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient
study. The total duration of the study is 3 months.

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