Linagliptin Inpatient Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Linagliptin; Basal Bolus; Linagliptin; Linagliptin + 50% Glargine dose on discharge; Linagliptin + 80% Glargine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Tradjenta; Glargine (Lantus) + aspart (Novolog) or lispro (Humalog); Trajenta; Trajenta, Lantus; Trajenta, Lantus
Intervention MeSH terms: Insulin Glargine; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Linagliptin; hospital hyperglycemia; inpatient diabetes