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

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ClinicalTrials.gov Identifier: NCT00394407
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : November 21, 2013
Sponsor:
Collaborators:
Sanofi
University of Miami
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 1, 2006
Last Update Posted Date November 21, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • 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.
Change History Complete list of historical versions of study NCT00394407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
  • frequency of hypoglycemia [ Time Frame: during the hospitalization ]
    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 ]
    evaluate differences in severe hyperglycemia between the 2 study arms
  • length of hospital stay [ Time Frame: during hospitalization ]
    differences in LOS between study arms
  • inflammatory markers [ Time Frame: during hospitalization ]
    C-reactive protein, interleukin-6, and tumor necrosis factor
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Official Title  ICMJE Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Hyperglycemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2006)
130
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394407
Other Study ID Numbers  ICMJE 419-2005
419-2005 ( Other Identifier: Other )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guillermo Umpierrez, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • Sanofi
  • University of Miami
Investigators  ICMJE
Principal Investigator: Guillermo E Umpierrez, MD Emory University
PRS Account Emory University
Verification Date November 2013

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