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

NCT00590044 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00005062a
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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).

Conditions

Diabetic Ketoacidosis

Keywords

Diabetic ketoacidosis; insulin therapy; DKA

Outcome Measures

Primary Outcomes (1)

• Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups

  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 Outcomes (3)

• Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin

  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

  up to 20 hours

• Difference in Time in Hours to Resolution of DKA Between the 2 Groups

  up to 20 hours

Study Arms (2)

Insulin glargine+glulisine

EXPERIMENTAL

Daily insulin glargine + glulisine before meals

Drug: insulin glargine+ glulisine

Split-mixed NPH + Regular insulin

ACTIVE COMPARATOR

Split-mixed NPH + Regular insulin twice daily

Drug: NPH + Regular insulin

Interventions

insulin glargine+ glulisine DRUG

Daily insulin glargine + glulisine before meals

Also known as: glargine (Lantus) + glulisine (Apidra)

Insulin glargine+glulisine

NPH + Regular insulin DRUG

Split-mixed NPH + Regular insulin twice daily

Also known as: Isophane Insulin(NPH), Intermediate acting Insulin (NPH)

Split-mixed NPH + Regular insulin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron 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.

  PMID: 19366972 RESULT

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Insulin Glargine; insulin glulisine; Insulin

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Limitations and Caveats

The study included relatively small number of patients. The study also excluded patients with hypovolemic shock, comatose patients and patients who had acute myocardial ischemia, congestive heart failure, end-stage renal or hepatic failure..

Results Point of Contact

• Title: Guillermo Umpierrez
• Organization: Emory University SOM

geumpie@emory.edu

4047781663

Study Officials

• Guillermo Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

• Sidney Jones, MD

  University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 10, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 26, 2018
• Results First Posted: April 30, 2009

Record last verified: 2018-08

Locations

US (2)