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NCT03591458 · ClinicalTrials.gov registry record · Phase 2
Amitriptyline in Treating Hypoglycemia
A Phase 2 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03591458: Clinical Trial Phase 2 study, sponsored by University of Utah.
NCT03591458 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03591458, a Phase 2 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Patients with type 1 diabetes mellitus (T1DM) commonly experience hypoglycemia and develop impaired awareness of hypoglycemia. Many patients using continuous glucose monitoring (CGM) system to mitigate these complications, but continue to spend a significant amount of time in hypoglycemia. The long-term goal is to develop novel and readily available therapeutic approaches to improve hypoglycemia course and awareness in T1DM patients. The objective of this study is to determine whether amitriptyline will improve hypoglycemia course and the ability to recognize hypoglycemic events in T1DM patients who are using CGM.
Primary Outcome
Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values \< 70 mg/dL will be compared between the Amitriptyline and Placebo arms.
Interventions
- DRUG Placebo
- DRUG Amitriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2019-06-03 |
| Phase | Phase 2 |
Why NCT03591458 stopped before completion
NCT03591458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03591458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03591458 about?
NCT03591458 is a clinical study titled "Amitriptyline in Treating Hypoglycemia". Patients with type 1 diabetes mellitus (T1DM) commonly experience hypoglycemia and develop impaired awareness of hypoglycemia. Many patients using continuous glucose monitoring (CGM) system to mitigate these complications, but continue to spend a significant amount of time in hypoglycemia. The long-...
What is the current status of trial NCT03591458?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-08-01. Estimated completion is 2019-06-03.
What interventions are being tested in trial NCT03591458?
The interventions under investigation include: Placebo (DRUG), Amitriptyline (DRUG).
Who is sponsoring clinical trial NCT03591458?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03591458's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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