NCT03051243

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DM2

Interventions

Type	Name	Description
DRUG	Linagliptin and Basal Insulin	Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals
DRUG	Basal Insulin and Bolus Insulin	Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-11-01
• Completion: 2019-11-01
• First posted: 2017-02-13
• Last updated: 2017-09-11