NCT00920725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

June 12, 2009

Last Update Submit

August 14, 2012

Conditions

Diabetic Ketoacidosis

Keywords

DKA

Outcome Measures

Primary Outcomes (2)

  • Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6

    q 2 hours

  • Hours to achieve blood glucose less than 200mg/dl

    q 1 hour

Study Arms (3)

Subcutaneous Insulin

ACTIVE COMPARATOR

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

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

IV Regular Insulin

ACTIVE COMPARATOR

Intravenous Regular Insulin 0.1 units/kg/hour

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Intravenous Novolog Insulin

ACTIVE COMPARATOR

Intravenous Novolog Insulin 0.1 units/kg/hour

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Interventions

Insulin (Aspart Insulin [Novolog], Regular Insulin)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 InsulinIntravenous Novolog InsulinSubcutaneous Insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant
  • less than age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

InsulinInsulin Aspart

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Rema A Gupta, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

  • David Baldwin, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

December 1, 2007

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

US(1)