Comparison of Apidra to Regular Insulin in Hospitalized Patients
Information source: Carl T. Hayden VA Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type II
Intervention: Glulisine (Apidra) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Carl T. Hayden VA Medical Center Official(s) and/or principal investigator(s):
Christian Meyer, MD, Principal Investigator, Affiliation: Carl T. Hayden VA Medical Center
Overall contact:
Rosemarie A Vedda, PA-C, Phone: 602-277-5551, Ext: 6183, Email: Rosemarie.Vedda@va.gov
Summary
To compare Apidra (a rapid acting insulin analogue) with Regular insulin (fast acting) in
addition to the use of long acting insulin Glargine in hospitalized patients in terms of
efficacy and safety in blood glucose control and frequency of low blood glucose. Blood
glucose control along with incidence and rate of low blood glucose during the hospitalization
shall be of primary interest; length of hospital stay comparing the short acting insulin used
shall be the secondary interest.
Clinical Details
Official title: Comparison of Apidra to Regular Insulin in Hospitalized Patients
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Glycemic control, and incidence and rate of hypoglycemia.
Secondary outcome: Length of hospital stay.
Detailed description:
OBJECTIVES: To compare the rapid acting insulin analogue Apidra with regular insulin in
addition to insulin Glargine in hospitalized patients in terms of efficacy and safety, namely
Glycemic control and frequency of hypoglycemia. Glycemic control, and incidence and rate of
hypoglycemia during the hospitalization shall be the primary endpoints; length of hospital
stay according to the short acting insulin used shall be the secondary endpoint.
RESEARCH DESIGN: Randomized, prospective study.
METHODS: Inpatient single center study, planning to enroll 600 patients with type II diabetes
admitted to medical or surgical non-ICU service for three days or longer. Subjects will be
randomized to Apidra or regular insulin in a 1: 1 fashion. Insulin Glargine will be given once
a day for basal insulin in all subjects. 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. In addition, HbA1c, lipid profile
and a fasting plasma C-peptide will be obtained. Two days prior to the anticipated discharge,
another HbA1c will be done.
The incidence and the rate of hypoglycemia in each category shall be determined. During the
hospitalization, the average of blood glucose measurements at each time point of an 8-point
blood glucose profile will be compared; after the hospitalization the HbA1c shall be used.
Glycemic control will be compared between groups using ANCOVA adjusting for baseline HbA1c.
Hypoglycemic events will be compared between groups using logistic or Poisson regression;
length of stay will be compared between groups using survival analysis or the Mann Whitney U
test.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must be admitted to non-critical care units with expected length of stay of
at least three days.
- Subjects must be able to communicate meaningfully with the investigator and must be
legally competent to provide written informed consent.
- Subjects may be of either sex. Female subjects of child-bearing potential must be
non-lactating and have a negative pregnancy test before starting the study.
- Subjects must be diagnosed with T2DM or develop hyperglycemia (BG >180 mg/dl) during
hospitalization.
Exclusion Criteria:
- Subjects must not be admitted for 'observation' or for expected length of stay of less
than three days.
- Subjects must not have Type 1 Diabetes.
- Subjects must not be using rapid acting insulin analogues.
- Subjects must not be receiving nutrition via tube feedings.
Locations and Contacts
Rosemarie A Vedda, PA-C, Phone: 602-277-5551, Ext: 6183, Email: Rosemarie.Vedda@va.gov
Carl T. Hayden VA Medical Center, Phoenix, Arizona 85012, United States; Recruiting
Rosemarie A Vedda, PA-C, Phone: 602-277-5551, Ext: 6183, Email: Rosemarie.Vedda@va.gov
Elena Plummer, MD, Phone: 602-277-5551, Ext: 5673, Email: Elena.Plummer@va.gov
Christian Meyer, MD, Principal Investigator
Elena Plummer, MD, Sub-Investigator
Additional Information
Starting date: June 2007
Ending date: May 2009
Last updated: September 11, 2007
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