Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
- Conditions
- DM2
- Interventions
- Drug: Basal Insulin and Bolus Insulin
- Registration Number
- NCT03051243
- Lead Sponsor
- Rabin Medical Center
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linagliptin and Basal Insulin Linagliptin and Basal Insulin linagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time. Basal Insulin and Bolus Insulin Basal Insulin and Bolus Insulin Basal Insulin (Glargine Lantus; Sanofi) based therapy once daily before bedtime and glulisine (Apidra; sanofi) before meals. insulin dose will be 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals.
- Primary Outcome Measures
Name Time Method Percentage of patient with mean blood glucose levels After firts day from admission and Up to 14 days, 3 and 6 month after discharge. between 80-180 mg/dl.
- Secondary Outcome Measures
Name Time Method Difference in BG values within range After firts day from admission and Up to 14 days, 3 and 6 month after discharge 140-180 mg/dl.
Number of hypoglycemic events (BG <70 and or < 40 mg/dL). After firts day from admission and Up to 14 days, 3 and 6 month after discharge \<70 and or \< 40 mg/dL
Number of episodes of hyperglycemia After firts day from admission and Up to 14 days, 3 and 6 month after discharge \>240 mg/dL
TTD (total daily dose) of insulin After firts day from admission and Up to 14 days, 3 and 6 month after discharge units of insulin