Status:
TERMINATED
Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting
Lead Sponsor:
Riverside University Health System Medical Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Detailed Description
The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a particular preparation, but also on patient specific factors which includes state of inflammation, obesity etc....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02189395
Start Date
April 1 2013
End Date
April 1 2017
Last Update
September 28 2017
Active Locations (1)
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1
Riverside County Regional Medical Center
Moreno Valley, California, United States, 92555