Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85
 years old with known with history of DM for more than 3 months and an average of two
 consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral
 antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1
 ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal
 insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once
 daily and glulisine (Apidra; sanifi) before meals.

 Patient will be discharged according to discharged protocol. Follow-up visits will take place
 at 3 and 6 months post discharged.
patient in the linagliptin plus basal insulin will receive linagliptin at single dose of 5
 mg/day, and a starting total daily dose (TDD) of glargine of 0.3 units/kg/day, while patients
 >70 years of age and/or with a serum creatinine >2.0 mg/dL will receive starting TDD of 0.15
 units/kg.

 Patient in the basal bolus group will start at a TDD of 0.5 units/kg divided half as insulin
 glargine once daily and half as insulin glulisine before meals. In patients >70 years of age
 and/or with a serum creatinine >2.0 mg/dL, the starting TDD will be reduce to 0.3 units/kg.

 The results of BG values will be measured as 2 hour pre meal glucose, bedtime glucose, and
 mean daily BG after first day at hospital, HbA1c will be measured on the first day of
 hospitalization.

 Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive
 correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2
 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.

 Hypoglycemic events shall be documented as well. In case of treatment failure, defined as
 average blood glucose levels or two consecutive measurements of more than 240 mg/dl,
 patient's treatment will be changed to basal based regimen.Patient with pre-meal and bed time
 blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin
 based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of
 insulin, 350-400 4 units of insulin.

 Hypoglycemic events shall be documented as well. In case of treatment failure, defined as
 average blood glucose levels or two consecutive measurements of more than 240 mg/dl,
 patient's treatment will be changed to basal based regimen.

 Patient will be discharged according to discharged protocol. Follow-up visits will take place
 at 3 and 6 months post discharged.

 Patients will be instructed to measure and record BG levels (pre meal glucose, bedtime
 glucose, and mean daily BG) during three days before follow-ups visits.
Inclusion Criteria:

 -  Male & female patient with Known history of DM for more than 3 months before
 randomization.

 -  Hospital admission due to blood glucose levels ranging between 180-400 mg/dl.

 -  Average of two consecutive blood glucose levels above 180 mg/dl.

 -  Age between 18 and 85 years old.

 -  Home treatment with diet alone, any combination of oral antidiabetic agents, or
 insulin therapy at daily dose <0.4 units/kg.

 Exclusion Criteria:

 -  BG >400 mg/dl in the period before randomization.

 -  Prior history of hyperglycemic crises.

 -  Have hyperglycemia without history of diabetes.

 -  Patient who expected ICU admission or cardiac surgery.

 -  A history of pancreatitis, active gallbladder disease, Corticosteroid therapy or
 hepatic disease.

 -  Impaired renal function (glomerular filtration rate [GFR] <30 mL/min or serum
 creatinine ≥3.0 mg/dL).

 -  History of diabetic ketoacidosis.

 -  Pregnancy.

 -  Inability to give informed consent (poor mental status).