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NCT03970720 · ClinicalTrials.gov registry record · Phase 2
Restoration of Hypoglycemia Awareness With Metoclopramide
A Phase 2 study of Hypoglycemia Unawareness, sponsored by Simon Fisher.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT03970720: Recruiting Phase 2 study of Hypoglycemia Unawareness, sponsored by Simon Fisher.
NCT03970720 is a Phase 2 study of Hypoglycemia Unawareness that is actively recruiting participants, run by Simon Fisher. The registered enrollment target is 36 participants, above the 12-participant average among 3 other Hypoglycemia Unawareness trials with a reported enrollment target (200% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970720, a Phase 2 study of Hypoglycemia Unawareness, is actively recruiting participants, sponsored by Simon Fisher.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.
Primary Outcome
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood glucagon level will be compared between the study arms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metoclopramide
Study Locations (2)
Kentucky
- University of Kentucky - Lexington
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03970720 shows while recruiting
NCT03970720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, above the 12-participant average among 3 other Hypoglycemia Unawareness trials with a reported enrollment target (200% higher).
The record links to 1 condition, with Hypoglycemia Unawareness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03970720 reports a single indexed study location in Kentucky, Utah.
Frequently Asked Questions
What is clinical trial NCT03970720 about?
NCT03970720 is a clinical study titled "Restoration of Hypoglycemia Awareness With Metoclopramide". Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia...
What is the current status of trial NCT03970720?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2019-05-28. Estimated completion is 2027-12-31.
What conditions does trial NCT03970720 study?
This clinical trial studies the following conditions: Hypoglycemia Unawareness.
What interventions are being tested in trial NCT03970720?
The interventions under investigation include: Placebo (DRUG), Metoclopramide (DRUG).
Who is sponsoring clinical trial NCT03970720?
This trial is sponsored by Simon Fisher, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03970720 being conducted?
This trial has 2 study locations across Kentucky, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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