drugset / Trial / NCT03660553

Simplified Insulin Regimen for the Elderly

NCT03660553

Phase 4 Terminated 7 enrolled University of Miami
RandomizedParallel-groupOpen-labelTreatment

Summary

Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age \>65 years) with type 2 diabetes.

Timeline

Start
2018-10-10
Primary completion
2022-06-30
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Lispro Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Comparator insulin aspart Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.4 iu/kg Subcutaneous