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NCT02004366 · ClinicalTrials.gov registry record · Phase 4
Linagliptin Inpatient Trial
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 295
- Enrollment target
NCT02004366: Completed Phase 4 study, sponsored by Emory University.
NCT02004366 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 295 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02004366, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 295 participants
- Enrollment target
Study Summary
This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are \> 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
Primary Outcome
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Interventions
- DRUG Linagliptin
- DRUG Basal Bolus
- DRUG Linagliptin + 50% Glargine dose on discharge
- DRUG Linagliptin + 80% Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-03 |
| Phase | Phase 4 |
What the finished NCT02004366 record still lists
NCT02004366 is an interventional study that assigns participants to a tested intervention. The registered 295 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 (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Linagliptin is the first listed.
NCT02004366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02004366 about?
NCT02004366 is a clinical study titled "Linagliptin Inpatient Trial". This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given cor...
What is the current status of trial NCT02004366?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 295 participants. The study started on 2014-01. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02004366?
The interventions under investigation include: Linagliptin (DRUG), Basal Bolus (DRUG), Linagliptin + 50% Glargine dose on discharge (DRUG), Linagliptin + 80% Glargine (DRUG).
Who is sponsoring clinical trial NCT02004366?
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 NCT02004366's enrollment target sits among peer trials
295 294th of 2000 higher than 1,706 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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