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Use of Insulin Glargine to Treat Diabetic Ketoacidosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sheila McMorrow, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179127
First received: September 13, 2005
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Early Use of Insulin Glargine in Diabetic Ketoacidosis

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 75
Study Start Date: August 2004
Estimated Study Completion Date: September 2012
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: glargine
0.3u/kg of glargine, subq, once
Placebo Comparator: B 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

Locations
United States, Tennessee
Vanderbilt University Monroe Carell Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sheila McMorrow, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Sheila McMorrow, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179127     History of Changes
Other Study ID Numbers: 040643
Study First Received: September 13, 2005
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013