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NCT01845831 · ClinicalTrials.gov registry record · Phase 4
Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 292
- Enrollment target
NCT01845831 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 292 participants.
The verdict
NCT01845831, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 292 participants
- Enrollment target
Study Summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot study aiming to determine differences in glycemic control between treatment with sitagliptin (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general medicine and surgery patients with type 2 diabetes (T2D). The investigators found that treatment with sitagliptin alone or in combination with basal insulin resulted in similar glycemic control compared to basal bolus regimen. The investigators will conduct a prospective RCT aimed to determine the safety and efficacy of sitagliptin therapy for in-hospital and post-discharge management of general medicine and surgical patients with T2D. A total of 280 patients with known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group 2). If needed, patients in the treatment groups will receive correction doses of rapid-acting insulin in the presence of hyperglycemia (BG \> 140 mg/dl). The overall hypothesis is that treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in hospital and post-discharge glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals. Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University of Michigan, Ohio State University and Temple University
Interventions
- DRUG Sitagliptin
- DRUG Glargine
- DRUG Basal Bolus
- DRUG Metformin and Sitagliptin
- DRUG Glargine 50%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01845831
The ClinicalTrials.gov registry entry for NCT01845831 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 292 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 5 interventions - of which Sitagliptin is the first listed.
NCT01845831 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01845831 about?
NCT01845831 is a clinical study titled "Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes". High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection i...
What is the current status of trial NCT01845831?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 292 participants. The study started on 2013-08. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01845831?
The interventions under investigation include: Sitagliptin (DRUG), Glargine (DRUG), Basal Bolus (DRUG), Metformin and Sitagliptin (DRUG), Glargine 50% (DRUG).
Who is sponsoring clinical trial NCT01845831?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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