Linagliptin Inpatient Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Linagliptin; Basal Bolus; Linagliptin; Linagliptin + 50% Glargine dose on discharge; Linagliptin + 80% Glargine
Intervention description: Linagliptin once daily + correction doses of rapid acting insulin if needed; Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed; Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.; Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.; Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.
Intervention MeSH terms: Insulin Glargine; Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; Linagliptin; hospital hyperglycemia; inpatient diabetes

Summary:

      This study is a prospective, randomized, open label trial to compare the safety and efficacy
      of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin
      regimen of glargine once daily plus rapid-acting insulin before meals. Both of these
      treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart,
      lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.

      The patients will be monitored for their blood sugars while the hospital.

      If patients are agreeable to participate in the discharge part of the study, the
      investigators will randomized them to a treatment group based on their admission HbA1c. The
      investigators will follow these patients for 3 months with phone calls and clinic visits, and
      will monitor their blood sugars. This is to compare the efficacy of linagliptin and our
      discharge treatment algorithm in controlling blood sugars as out patients.
    

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