Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Sanofi
University of Miami
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00394407
First received: October 31, 2006
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).


Condition Intervention Phase
Diabetes
Hyperglycemia
Drug: sliding scale regular insulin
Drug: glargine basal insulin and glulisine prandial insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • blood glucose control [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
    Differences in BG control will be assessed between the 2 arms acqhs and as needed for those patients hospitalized on the non-medical floors


Secondary Outcome Measures:
  • frequency of hypoglycemia [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
    assess differences in the frequency of hypoglycemia between the 2 study arms

  • frequency of severe hyperglycemia (BG > 400 mg/dl), [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
    evaluate differences in severe hyperglycemia between the 2 study arms

  • length of hospital stay [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
    differences in LOS between study arms

  • inflammatory markers [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
    C-reactive protein, interleukin-6, and tumor necrosis factor


Enrollment: 130
Study Start Date: September 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sliding scale regular insulin
sliding scale insulin given acqhs
Drug: sliding scale regular insulin
SSRI acqhs
Other Name: Novolin-R
Active Comparator: glargine insulin and glulisine insulin
glargine basal insulin once a day with prandial glulisine insulin tid
Drug: glargine basal insulin and glulisine prandial insulin
glargine insulin once a day and glulisine insulin three times a day as long as patient eating
Other Name: Lantus inuslin, Apidra insulin

Detailed Description:

This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2 diabetes and elevated blood glucose (sugar) levels. Lantus is a long-acting insulin which is given subcutaneously (under the skin) once daily. Apidra is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Regular insulin is a short-acting insulin in clinical use for more than 20 years that is also given subcutaneously several times per day. Lantus, Apidra and regular insulins are approved for use in the treatment of patients with diabetes by the FDA.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Jackson Memorial Hospital, Miami. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Jackson Memorial Hospital. This study is supported by Sanofi-Aventis Pharmaceuticals.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females between the ages of 18 and 70 years admitted to a general medicine service.
  2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
  3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

  1. Subjects with increased blood glucose concentration, but without a known history of diabetes.
  2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [57].
  3. Patients with known HIV, acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo surgery during the hospitalization course.
  4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0.
  5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  6. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
  7. Female subjects are pregnant or breast feeding at time of enrollment into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394407

Locations
United States, Florida
University of Miami School of Medicine
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
Emory University
Sanofi
University of Miami
Investigators
Principal Investigator: Guillermo E Umpierrez, MD Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00394407     History of Changes
Other Study ID Numbers: 419-2005, 419-2005
Study First Received: October 31, 2006
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
inpatient
diabetes management
insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014