Type 2 Diabetes Clinical Trial
Official title:
Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
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.
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.
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