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

• Males or female surgical non-ICU patients ages between18 and 80 years
• 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.
• 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

• Age < 18 or > 80 years.
• Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
• 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).
• Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
• Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
• Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
• Patients with clinically relevant pancreatic or gallbladder disease.
• Patients with previous history of pancreatitis
• Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
• Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Pregnancy or breast feeding at time of enrollment into the study.
• Patients who received supplemental sliding scale insulin >72 hours prior to randomization
• Patients who received basal insulin > 48 hours prior to randomization