drugset / Trial / NCT03051243

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

NCT03051243

Phase 3 Unknown 60 enrolled Rabin Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-10-01
Primary completion
2018-11-01
Completion
2019-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Basal Insulin and Bolus Insulin Unknown 0.15 iu/kg
Comparator Basal Insulin and Bolus Insulin Unknown 0.25 iu/kg
Comparator Linagliptin Small molecule 5 mg
Comparator insulin glargine Protein / enzyme biologic 0.15 iu/kg
Comparator insulin glargine Protein / enzyme biologic 0.25 iu/kg
Comparator insulin glargine Protein / enzyme biologic 0.3 iu/kg