Clinical trial NCT03051243: Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
Official title: Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: DM2
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Percentage of patient with mean blood glucose levels
timeFrame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge.
Secondary outcomes:
measure: Difference in BG values within range
timeFrame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
measure: Number of hypoglycemic events (BG <70 and or < 40 mg/dL).
timeFrame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
measure: Number of episodes of hyperglycemia
timeFrame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
measure: TTD (total daily dose) of insulin
timeFrame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Other outcomes:
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