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

Stopped early · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02189395

Run by

Riverside University Health System Medical Center

People needed

52

Starts

2013-04-01

Expected to finish

2017-04-01

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Riverside County Regional Medical Center — Moreno Valley, California, United States

Full record on ClinicalTrials.gov

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