COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394407
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : November 21, 2013
University of Miami
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Hyperglycemia Drug: sliding scale regular insulin Drug: glargine basal insulin and glulisine prandial insulin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. blood glucose control [ Time Frame: During hospitalization ]
    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 :
  1. frequency of hypoglycemia [ Time Frame: during the hospitalization ]
    assess differences in the frequency of hypoglycemia between the 2 study arms

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

  3. length of hospital stay [ Time Frame: during hospitalization ]
    differences in LOS between study arms

  4. inflammatory markers [ Time Frame: during hospitalization ]
    C-reactive protein, interleukin-6, and tumor necrosis factor

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394407

Layout table for location information
United States, Florida
University of Miami School of Medicine
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
Emory University
University of Miami
Layout table for investigator information
Principal Investigator: Guillermo E Umpierrez, MD Emory University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University Identifier: NCT00394407    
Other Study ID Numbers: 419-2005
419-2005 ( Other Identifier: Other )
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Keywords provided by Guillermo Umpierrez, Emory University:
diabetes management
insulin therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs