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

October 31, 2006
November 20, 2013
September 2005
June 2006   (final data collection date for primary outcome measure)
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
  • The primary outcome of the study is to determine differences in glycemic
  • control as measured by mean daily blood glucose concentration between
  • insulin glargine once daily plus supplemental glulisine insulin versus
  • sliding scale regular insulin in hospitalized patients with type 2 diabetes.
Complete list of historical versions of study NCT00394407 on ClinicalTrials.gov Archive Site
  • 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
  • Secondary outcomes include differences between treatment groups in any of
  • the following measures: number of hypoglycemic events (BG < 60 mg/dl),
  • number of episodes of severe hyperglycemia (BG > 400 mg/dl),
  • length of hospital stay, and concentration of vascular inflammatory
  • markers [C-reactive protein, interleukin-6, and tumor necrosis factor –alpha.
Not Provided
Not Provided
 
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Hyperglycemia
  • Drug: sliding scale regular insulin
    SSRI acqhs
    Other Name: Novolin-R
  • 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
  • Active Comparator: sliding scale regular insulin
    sliding scale insulin given acqhs
    Intervention: Drug: sliding scale regular insulin
  • Active Comparator: glargine insulin and glulisine insulin
    glargine basal insulin once a day with prandial glulisine insulin tid
    Intervention: Drug: glargine basal insulin and glulisine prandial insulin
Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. Epub 2007 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
June 2006
June 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394407
419-2005, 419-2005
Yes
Guillermo Umpierrez, Emory University
Emory University
  • Sanofi
  • University of Miami
Principal Investigator: Guillermo E Umpierrez, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP