Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

NCT00591227 | Completed Phase 4 Results

• 1 other identifier: 07070902
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  hospital length of stay in days

  from hospital admission to hospital discharge

Secondary Outcomes (4)

• Average Blood Glucose During the Hospital Admission

  from admission to discharge

• Frequency of Hypoglycemia

  from hospital admission to discharge

• Efficacy of Blood Glucose Lowering During the Emergency Room Stay

  from emergency room admission to discharge

• Frequency of Hypoglycemia During Emergency Room Therapy With Insulin

  from emergency room admission to discharge

Study Arms (2)

aspart detemir

ACTIVE COMPARATOR

these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.

Drug: insulin aspart; Drug: insulin detemir

usual care

NO INTERVENTION

these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.

Interventions

insulin aspart DRUG

insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.

aspart detemir

insulin detemir DRUG

insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.

aspart detemir

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years
• History of type 2 diabetes mellitus for at least 3 months
• Prior therapy with dietary management, oral agents, or insulin
• Non child-bearing potential or a negative urine pregnancy test
• Initial blood glucose in ER \> 200 mg/dl

You may not qualify if:

• Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
• Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
• History of current drug or alcohol abuse.
• History of current mental illness
• Inability to give informed consent
• Female patients who are pregnant or are breast feeding
• Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal
• Patients currently treated with dialysis

Sponsors & Collaborators

• Rush University Medical Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Bernard JB, Munoz C, Harper J, Muriello M, Rico E, Baldwin D. Treatment of inpatient hyperglycemia beginning in the emergency department: a randomized trial using insulins aspart and detemir compared with usual care. J Hosp Med. 2011 May;6(5):279-84. doi: 10.1002/jhm.866.

  PMID: 21661100 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Baldwin MD
• Organization: Rush University Medical Center

david_baldwin@rush.edu

312-942-6163

Study Officials

• David Baldwin, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 7, 2022
• Results First Posted: May 5, 2011

Record last verified: 2022-01

Locations

US (1)