Comparison of Apidra to Regular Insulin in Hospitalized Patients

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Diabetes Mellitus, Type II
Interventions
DRUG

Glulisine (Apidra)

An algorithm to determine the initial doses of insulin and dose adjustments is as follows: Lean subjects (BMI less than 25 kg/m2) will initially receive a total of 0.4 units/kg/day, overweight subjects (BMI 25-30 kg/m2) 0.5 units/kg/day and obese subjects (BMI greater than 30 kg/m2) 0.6 units/kg/day. Fifty percent of the total amount of insulin will be given as Glargine and 50% as regular insulin or Apidra. Supplemental short-acting insulin will be given for hyperglycemia before meals. Automated order sets shall be generated to minimize errors in order entries. Glucose concentrations will be measured before each meal and at bedtime, and if symptomatic. In addition, eight-point blood glucose profiles will be obtained every three days starting on day 2. Dose adjustments will be made to keep blood glucose concentrations between 80 and 120 mg/dl pre-prandially and less than180 mg/dl after meals.

Trial Locations (1)

85012

Phoenix VA Health Care System, Phoenix

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Carl T. Hayden VA Medical Center

FED