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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carl T. Hayden VA Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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