Type 2 Diabetes Mellitus Clinical Trial
Official title:
Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
NCT number | NCT00591227 |
Other study ID # | 07070902 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | July 2009 |
Verified date | January 2022 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 176 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age 18-80 years 2. History of type 2 diabetes mellitus for at least 3 months 3. Prior therapy with dietary management, oral agents, or insulin 4. Non child-bearing potential or a negative urine pregnancy test 5. Initial blood glucose in ER > 200 mg/dl Exclusion Criteria: 1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation. 2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention. 3. History of current drug or alcohol abuse. 4. History of current mental illness 5. Inability to give informed consent 6. Female patients who are pregnant or are breast feeding 7. Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) > 3 times the upper range of normal 8. Patients currently treated with dialysis |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Novo Nordisk A/S |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Length of Stay | hospital length of stay in days | from hospital admission to hospital discharge | |
Secondary | Average Blood Glucose During the Hospital Admission | from admission to discharge | ||
Secondary | Frequency of Hypoglycemia | from hospital admission to discharge | ||
Secondary | Efficacy of Blood Glucose Lowering During the Emergency Room Stay | from emergency room admission to discharge | ||
Secondary | Frequency of Hypoglycemia During Emergency Room Therapy With Insulin | from emergency room admission to discharge |
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