DM2
Conditions
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.
Interventions
DRUGLinagliptin and Basal Insulin
Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals
Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed