- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00590044
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
August 30, 2018 updated by: Guillermo Umpierrez, MD, Emory University
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
74
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin glargine+glulisine
Daily insulin glargine + glulisine before meals
|
Daily insulin glargine + glulisine before meals
Other Names:
|
Active Comparator: Split-mixed NPH + Regular insulin
Split-mixed NPH + Regular insulin twice daily
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Split-mixed NPH + Regular insulin twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days after transitioning to subcutaneous insulin
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin
|
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.
|
up to 20 hours
|
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.
|
up to 20 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00005062a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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