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NCT00590226 · ClinicalTrials.gov registry record · Phase 4
Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT00590226 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 130 participants.
The verdict
NCT00590226, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.
Interventions
- DRUG Detemir + aspart insulin before meals
- DRUG NPH insulin + regular insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590226
The ClinicalTrials.gov registry entry for NCT00590226 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Detemir + aspart insulin before meals is the first listed.
NCT00590226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590226 about?
NCT00590226 is a clinical study titled "Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes". High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insul...
What is the current status of trial NCT00590226?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2006-12. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00590226?
The interventions under investigation include: Detemir + aspart insulin before meals (DRUG), NPH insulin + regular insulin (DRUG).
Who is sponsoring clinical trial NCT00590226?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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