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

NCT ID: NCT00920725

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Ketoacidosis

Keywords

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DKA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous Insulin

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

Group Type ACTIVE_COMPARATOR

Insulin (Aspart Insulin [Novolog], Regular Insulin)

Intervention Type DRUG

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

IV Regular Insulin

Intravenous Regular Insulin 0.1 units/kg/hour

Group Type ACTIVE_COMPARATOR

Insulin (Aspart Insulin [Novolog], Regular Insulin)

Intervention Type DRUG

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

Intravenous Novolog Insulin

Intravenous Novolog Insulin 0.1 units/kg/hour

Group Type ACTIVE_COMPARATOR

Insulin (Aspart Insulin [Novolog], Regular Insulin)

Intervention Type DRUG

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Baldwin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rema A Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

David Baldwin, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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05012103

Identifier Type: -

Identifier Source: org_study_id