Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
David Baldwin, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00920725
First received: June 12, 2009
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.


Condition Intervention
Diabetic Ketoacidosis
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6 [ Time Frame: q 2 hours ] [ Designated as safety issue: No ]
  • Hours to achieve blood glucose less than 200mg/dl [ Time Frame: q 1 hour ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcutaneous Insulin
Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

Active Comparator: IV Regular Insulin
Intravenous Regular Insulin 0.1 units/kg/hour
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

Active Comparator: Intravenous Novolog Insulin
Intravenous Novolog Insulin 0.1 units/kg/hour
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: age 18 or older

  • venous pH < 7.3 or arterial < 7.35
  • at least 2 of the following 3:

    1. serum HCO3 < 18/anion gap > 16
    2. serum glucose > 300 mg/dl
    3. serum acetone positive

Exclusion Criteria:

  • pregnant
  • less than age 18
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920725

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Novo Nordisk A/S
Investigators
Principal Investigator: Rema A Gupta, MD Rush University Medical Center
Principal Investigator: David Baldwin, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: David Baldwin, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00920725     History of Changes
Other Study ID Numbers: 05012103
Study First Received: June 12, 2009
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
DKA

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acid-Base Imbalance
Acidosis
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014