The purpose of this study is to compare the safety and effectiveness of the two different basal insulins commonly used for basal blood sugar control in the treatment of type 2 diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of blood sugar in a type 2 diabetic patient. This research is being done because the costs of medications for diabetic patients are very expensive. Our goal with this research is to show that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin \[glargine (Lantus®)\] in patients with type 2 diabetes mellitus who are in the hospital.
This is a randomized, open label trial comparing effectiveness of insulin glargine and insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an intervention (NPH) or a control group (glargine) upon admission. The following data will be collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C, blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of hospitalization, insulin dose, and discharge status. Data will be recorded and maintained confidentially.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.
NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.
Inova Fairfax Hospital
Falls Church, Virginia, United States
Mean daily blood glucose
Time frame: 5 days
Percent of total BG readings within target BG 70-180 mg/dL before meals.
Time frame: 5 days
Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL)
Time frame: 5 days
Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment.
Time frame: 5 days
Hospital mortality
Time frame: 5 days
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