Trial record 3 of 15 for:    "Diabetic Ketoacidosis"

Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00590044
First received: December 28, 2007
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an estimated 100,000 admissions per year in the United States, DKA is also the leading cause of death in children with type 1 diabetes, and accounts for a significant proportion of admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies have reported successful protocols for insulin administration during the acute management of DKA, but they have failed to address the transition phase from IV to SC maintenance insulin regimen. The American Diabetes Association (ADA) position statement recommends the use of split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This regimen, however, are associated with a high rate of hyperglycemia shortly after discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently, the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been shown to facilitate glycemic control with lower rate of hypoglycemic events than intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i) to determine the effects of giving a dose of glargine insulin shortly after starting an intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient glycemic control in patients with DKA.

This investigator initiated research will be conducted at Grady Memorial Hospital, Atlanta and at University of Minnesota, MN. Dr Umpierrez designed the study and will serve as principal investigator. A total of 40 patients will be recruited at each site.


Condition Intervention Phase
Diabetic Ketoacidosis
Drug: insulin glargine+ glulisine
Drug: NPH + Regular insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Basal Insulin in the Management of Patients With Diabetic Ketoacidosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Mean Daily Blood Glucose Concentration After the Resolution of DKA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups.


Secondary Outcome Measures:
  • Mean Daily Blood Glucose Concentration While on the Insulin Drip [ Time Frame: blood glucose (BG) before meals and at bedtime ] [ Designated as safety issue: No ]
    determine differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA)

  • Frequency of Hypoglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ] [ Designated as safety issue: Yes ]
    differences between treatment groups in the number of hypoglycemic events (blood glucose < 60 mg/dl) between hours 12 to 36 (second day)

  • Frequency of Hyperglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ] [ Designated as safety issue: Yes ]
    differences between treatment groups in the number of hyperglycemic episodes (blood glucose > 200 mg/dl).


Enrollment: 74
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glargine (Lantus) + glulisine (Apidra)
Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
Drug: insulin glargine+ glulisine
Daily insulin glargine + glulisine before meals
Other Name: glargine (Lantus) + glulisine (Apidra)
Active Comparator: Split-mixed NPH + Regular insulin
Split-mixed NPH + Regular insulin twice daily
Drug: NPH + Regular insulin
Split-mixed NPH + Regular insulin twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA and who are willing to participate in the study protocol will be considered candidates for inclusion into the study.
  • Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous pH < 7.3, serum bicarbonate < 18 mEq/L, and moderate to severe ketonemia (acetoacetate ≥ 1:4 or β-hydroxybutyrate > 3 mmol).

Exclusion Criteria:

  • Hemodynamic instability (MAP < 50 or patients requiring pressor)
  • Significant identifiable medical or surgical illness, including but not limited to: acute myocardial infarction, congestive heart failure; respiratory failure requiring mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0 mg/dl); end stage liver failure, and cirrhosis.
  • Patients with dementia or persistent altered mental status that would prevent collection of consent form and reliable information.
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590044

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Minnesota
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
Study Chair: Sidney Jones, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00590044     History of Changes
Other Study ID Numbers: IRB00005062a
Study First Received: December 28, 2007
Results First Received: January 30, 2009
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Diabetic ketoacidosis
insulin therapy
DKA

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

ClinicalTrials.gov processed this record on August 21, 2014