ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 36 for:    DKA | "Diabetic Ketoacidosis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00590044
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : April 30, 2009
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Brief Summary:
The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

Condition or disease Intervention/treatment Phase
Diabetic Ketoacidosis Drug: insulin glargine+ glulisine Drug: NPH + Regular insulin Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basal Insulin in the Management of Patients With Diabetic Ketoacidosis
Study Start Date : December 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin glargine+glulisine
Daily insulin glargine + glulisine 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
Other Names:
  • Isophane Insulin(NPH)
  • Intermediate acting Insulin (NPH)




Primary Outcome Measures :
  1. Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups [ Time Frame: 5 days after transitioning to subcutaneous insulin ]
    To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.


Secondary Outcome Measures :
  1. Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin [ Time Frame: Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin ]
    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. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972.

  2. Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups [ Time Frame: up to 20 hours ]
    To determine the 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) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.

  3. Difference in Time in Hours to Resolution of DKA Between the 2 Groups [ Time Frame: up to 20 hours ]
    The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 phenol hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to severe ketonemia (acetoacetate ≥ 1:4 or βeta-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00590044     History of Changes
Other Study ID Numbers: IRB00005062a
First Posted: January 10, 2008    Key Record Dates
Results First Posted: April 30, 2009
Last Update Posted: September 26, 2018
Last Verified: August 2018

Keywords provided by Guillermo Umpierrez, MD, 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
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs