drugset / Trial / NCT02189395

Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting

NCT02189395

Phase 4 Terminated 52 enrolled Riverside University Health System Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of the current study is to determine difference in glycemic control between traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly encountered in the investigators county hospital setting which include newly diagnosed type 2 patients and patients on relatively high dose of insulin (dose \>0.4 units/kg body weight. Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.

Timeline

Start
2013-04
Primary completion
2017-04
Completion
2017-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic
Comparator Insulin Lispro Protein / enzyme biologic
Subject Neutral Protamine Hagedorn Protein / enzyme biologic
Comparator insulin glargine Protein / enzyme biologic