drugset / Trial / NCT03051243
Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |