drugset / Trial / NCT03511521

Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

NCT03511521 ↗

Phase 4 Terminated 3 enrolled Northwestern University
RandomizedParallel-groupOpen-labelTreatment

Summary

Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions. There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin, an intermediate-acting insulin, given at the time of steroid administration to the patient's standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen which will consist primarily increasing the prandial doses at lunch and supper in order to determine which regimen is superior for glycemic control.

Timeline

Start
2018-03-27
Primary completion
2019-08-15
Completion
2019-08-15

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to recruit sufficient number of patients”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject NPH insulin Protein / enzyme biologic — —
Subject insulin aspart Protein / enzyme biologic 0.08 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.1 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.15 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.2 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.25 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.3 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.35 iu/kg —
Subject insulin aspart Protein / enzyme biologic 0.4 iu/kg —
Subject insulin glargine Protein / enzyme biologic 0.25 iu/kg —
Subject insulin glargine Protein / enzyme biologic 0.3 iu/kg —

Indications