Use of Insulin Glargine to Treat Diabetic Ketoacidosis ...

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

This study is currently recruiting participants.
Verified by Vanderbilt University, September 2008

Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179127
Purpose

The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.

Condition Intervention
Diabetic Ketoacidosis
Drug: glargine
Drug: saline

Drug Information available for: Insulin Insulin glargine Sodium chloride

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Early Use of Insulin Glargine in Diabetic Ketoacidosis

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

* Time of acidosis correction [ Time Frame: Minutes ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Time on insulin drip [ Time Frame: Minutes ] [ Designated as safety issue: No ]
* Total hospital stay [ Time Frame: Days ] [ Designated as safety issue: No ]


Estimated Enrollment: 75
Study Start Date: August 2004
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator Drug: glargine
0.3u/kg of glargine, subq, once
B: Placebo Comparator Drug: saline
0.3cc/kg of saline, subq, once

Eligibility
Ages Eligible for Study: 6 Years to 18 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* Ages 6-18 y.o. presenting to VCH E.R. with:
* Established history of insulin dependent diabetes

AND:

* Chief c/o hyperglycemia or vomiting
* Venous pH < 7.24
* Serum Bicarbonate < 18
* Blood glucose > 150
* Urinary Ketones

Exclusion Criteria:

* Age < 6y.o.
* New onset diabetes
* Received IV insulin bolus prior to arrival to VCH E.R.
* Venous pH > 7.24
* Serum Bicarbonate > 18
* Pregnancy
* Received glargine within 12 hours prior to arrival to VCH E.R./PCCU

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179127

Contacts
Contact: Sheila McMorrow, MD 615-343-2996 Sheila.McMorrow@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Monroe Carell Children's Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sheila McMorrow, MD 615-343-2996 Sheila.McMorrow@vanderbilt.edu

Sponsors and Collaborators
Vanderbilt University

Investigators
Principal Investigator: Sheilea McMorrow, MD Vanderbilt University
More Information


Responsible Party: Vanderbilt University Medical Center ( Sheila McMorrow, MD )
Study ID Numbers: 040643
First Received: September 13, 2005
Last Updated: September 5, 2008
ClinicalTrials.gov Identifier: NCT00179127
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Pediatrics
Diabetes
Emergency Care
Endocrinology
Critical Care

Study placed in the following topic categories:
Metabolic Diseases
Glargine
Diabetes Mellitus
Endocrine System Diseases
Emergencies
Diabetic Ketoacidosis

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Diabetes Complications
Acidosis

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acid-Base Imbalance

ClinicalTrials.gov processed this record on October 23, 2008