safety and efficiency of linagliptin (trajenta) in the setting of internal medicine department

Conditions: DM2

Summary: 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.

Eligibility criteria:
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).