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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: Completed Phase 4 study, sponsored by Emory University.
NCT00590226 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 130 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2
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 |
What the finished NCT00590226 record still lists
NCT00590226 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Detemir + aspart insulin before meals is the first listed.
NCT00590226 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590226's enrollment target sits among peer trials
130 622nd of 2000 higher than 1,370 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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