Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus

Conditions
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DM2

Intervention / Treatment
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* Drug: Linagliptin and Basal Insulin
* Drug: Basal Insulin and Bolus Insulin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Linagliptin and Basal Insulin<br>linagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time. | Drug: Linagliptin and Basal Insulin<br>* Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals<br>* Other names: Trajenta (Linagliptin);|
| Active Comparator: Basal Insulin and Bolus Insulin<br>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. | Drug: Basal Insulin and Bolus Insulin<br>* Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals<br>* Other names: glulisine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient with mean blood glucose levels | between 80-180 mg/dl. | After firts day from admission and Up to 14 days, 3 and 6 month after discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in BG values within range | 140-180 mg/dl. | After firts day from admission and Up to 14 days, 3 and 6 month after discharge | 
| Number of hypoglycemic events (BG <70 and or < 40 mg/dL). | <70 and or < 40 mg/dL | After firts day from admission and Up to 14 days, 3 and 6 month after discharge | 
| Number of episodes of hyperglycemia | >240 mg/dL | After firts day from admission and Up to 14 days, 3 and 6 month after discharge | 
| TTD (total daily dose) of insulin | units of insulin | After firts day from admission and Up to 14 days, 3 and 6 month after discharge |