Comparison of Apidra to Regular Insulin in Hospitalized Patients (Apidra)

July 23, 2014 updated by: Carl T. Hayden VA Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Apidra
Direct 1:1 comparison of Apidra and Regular insulin.
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.
Active Comparator: Regular
Direct 1:1 comparison of Apidra and Regular insulin.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemic events
Time Frame: up to 60 days
up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl T. Hayden VA Medical Center

Collaborators

Sanofi

Investigators

  • Principal Investigator: Christian Meyer, MD, Carl T. Hayden VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meyer - 012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type II

Clinical Trials on Glulisine (Apidra)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe