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

Primary Purpose

Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin (Aspart Insulin [Novolog], Regular Insulin)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring DKA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Subcutaneous Insulin

IV Regular Insulin

Intravenous Novolog Insulin

Arm Description

Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours

Intravenous Regular Insulin 0.1 units/kg/hour

Intravenous Novolog Insulin 0.1 units/kg/hour

Outcomes

Primary Outcome Measures

Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
Hours to achieve blood glucose less than 200mg/dl

Secondary Outcome Measures

Full Information

First Posted
June 12, 2009
Last Updated
August 14, 2012
Sponsor
Rush University Medical Center
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00920725
Brief Title
Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA
Acronym
DKA
Official Title
Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis
Keywords
DKA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous Insulin
Arm Type
Active Comparator
Arm Description
Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours
Arm Title
IV Regular Insulin
Arm Type
Active Comparator
Arm Description
Intravenous Regular Insulin 0.1 units/kg/hour
Arm Title
Intravenous Novolog Insulin
Arm Type
Active Comparator
Arm Description
Intravenous Novolog Insulin 0.1 units/kg/hour
Intervention Type
Drug
Intervention Name(s)
Insulin (Aspart Insulin [Novolog], Regular Insulin)
Intervention Description
Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous
Primary Outcome Measure Information:
Title
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
Time Frame
q 2 hours
Title
Hours to achieve blood glucose less than 200mg/dl
Time Frame
q 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18 or older venous pH < 7.3 or arterial < 7.35 at least 2 of the following 3: serum HCO3 < 18/anion gap > 16 serum glucose > 300 mg/dl serum acetone positive Exclusion Criteria: pregnant less than age 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rema A Gupta, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Baldwin, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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