Comparison of Apidra to Regular Insulin in Hospitalized Patients - Full Text View

Sponsors and Collaborators:	Carl T. Hayden VA Medical Center Sanofi-Aventis
Information provided by:	Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:	NCT00528918

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type II	Drug: Glulisine (Apidra)

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin glargine Dextrose Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Comparison of Apidra to Regular Insulin in Hospitalized Patients

Further study details as provided by Carl T. Hayden VA Medical Center:

Primary Outcome Measures:

Glycemic control, and incidence and rate of hypoglycemia. [ Time Frame: During the hospitalization. ]

Secondary Outcome Measures:

Length of hospital stay. [ Time Frame: During the hospitalization. ]

Estimated Enrollment:	600
Study Start Date:	June 2007
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
Apidra: Active Comparator 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.
Regular: Active Comparator 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.

Arms

Assigned Interventions

Apidra: Active Comparator

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.

Regular: Active Comparator

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.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528918

Contacts

Contact: Rosemarie A Vedda, PA-C	602-277-5551 ext 6183	Rosemarie.Vedda@va.gov
Contact: Elena Plummer, MD	602-277-5551 ext 5673	Elena.Plummer@va.gov

Locations

United States, Arizona
Carl T. Hayden VA Medical Center	Recruiting
Phoenix, Arizona, United States, 85012
Contact: Rosemarie A Vedda, PA-C 602-277-5551 ext 6183 Rosemarie.Vedda@va.gov
Contact: Elena Plummer, MD 602-277-5551 ext 5673 Elena.Plummer@va.gov
Principal Investigator: Christian Meyer, MD
Sub-Investigator: Elena Plummer, MD

Sponsors and Collaborators

Carl T. Hayden VA Medical Center

Sanofi-Aventis

Investigators

Principal Investigator:

Christian Meyer, MD

Carl T. Hayden VA Medical Center

More Information

Study ID Numbers:	Meyer - 012
Study First Received:	September 11, 2007
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00528918
Health Authority:	United States: Federal Government; United States: Department of Veteran Affairs Office of Research Oversight

Keywords provided by Carl T. Hayden VA Medical Center:

diabetes
hyperglycemia
insulin
Apidra
Glargine

Study placed in the following topic categories:

Insulin glulisine
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009