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

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Riverside County Regional Medical Center; Riverside University Health System Medical Center
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Protamines

Criteria

Inclusion Criteria:

• Patients with type II diabetes regardless of duration of diagnosis with an admission blood glucose level between 140 mg/dL to 400 mg/dL will be included in the study.

• Other inclusion criteria are as follows:

• age 18-80 years old

• treated with diet alone

• any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.

Exclusion Criteria:

• Hyperglycemia without a known history of diabetes

• H/o recent cardiac surgery (within 6 months)

• Impaired renal function (glomerular filtration rate less than 45)

• History of diabetic ketoacidosis

• Diabetes mellitus type 1

• Pregnancy

• Patients on steroid treatment

• Known hypopituitarism or adrenal insufficiency

• Known hypoglycemia of unawareness

• Length of stay <48 h

• And severe liver disease and patent admitted in intensive care unit.

• Patients already received an insulin dose greater than 0.5 units/kg body weight after admission prior to initiation of study protocol will be excluded from the study.