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Comparison of Apidra to Regular Insulin in Hospitalized Patients

NCT00528918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-07-24

No results posted yet for this study

Summary

The purpose of this study is 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.

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Carl T. Hayden VA Medical Center

    lead FED

Principal Investigators

  • Christian Meyer, MD · Carl T. Hayden VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528918 on ClinicalTrials.gov