drugset / Trial / NCT02061969

ADA Linagliptin in Long Term Care

NCT02061969

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Timeline

Start
2014-04-25
Primary completion
2017-04-10
Completion
2017-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Linagliptin Small molecule 5 mg Oral
Comparator insulin glargine Protein / enzyme biologic 0.1 iu/kg