drugset / Trial / NCT02004366

Linagliptin Inpatient Trial

NCT02004366

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are \> 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.

Timeline

Start
2014-01
Primary completion
2017-02
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Linagliptin Small molecule 5 mg Oral
Subject insulin glargine Protein / enzyme biologic 0.15 unknown
Subject insulin glargine Protein / enzyme biologic 50 %
Subject insulin glargine Protein / enzyme biologic 80 %
Background Insulin Lispro Protein / enzyme biologic
Background insulin aspart Protein / enzyme biologic