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

NCT00394407 | Completed Phase 4 DMC

• 1 other identifier: 419-2005
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes; Hyperglycemia

Keywords

inpatient; diabetes management; insulin therapy

Outcome Measures

Primary Outcomes (1)

• blood glucose control

  Differences in BG control will be assessed between the 2 arms acqhs and as needed for those patients hospitalized on the non-medical floors

  During hospitalization

Secondary Outcomes (4)

• frequency of hypoglycemia

  during the hospitalization

• frequency of severe hyperglycemia (BG > 400 mg/dl),

  during the hospitalization

• length of hospital stay

  during hospitalization

• inflammatory markers

  during hospitalization

Study Arms (2)

sliding scale regular insulin

ACTIVE COMPARATOR

sliding scale insulin given acqhs

Drug: sliding scale regular insulin

glargine insulin and glulisine insulin

ACTIVE COMPARATOR

glargine basal insulin once a day with prandial glulisine insulin tid

Drug: glargine basal insulin and glulisine prandial insulin

Interventions

sliding scale regular insulin DRUG

SSRI acqhs

Also known as: Novolin-R

sliding scale regular insulin

glargine basal insulin and glulisine prandial insulin DRUG

glargine insulin once a day and glulisine insulin three times a day as long as patient eating

Also known as: Lantus inuslin, Apidra insulin

glargine insulin and glulisine insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 18 and 70 years admitted to a general medicine service.
• A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
• 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).

You may not qualify if:

• Subjects with increased blood glucose concentration, but without a known history of diabetes.
• Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[57\].
• 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.
• Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator
• University of Miami: collaborator

Study Sites (1)

University of Miami School of Medicine

Coral Gables, Florida, 33124, United States

Location

Related Publications (1)

• 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. doi: 10.2337/dc07-0295. Epub 2007 May 18.

  PMID: 17513708 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Guillermo E Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: September 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)