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NCT04028960 · ClinicalTrials.gov registry record · Phase 2
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
A Phase 2 study, sponsored by HealthPartners Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04028960: Clinical Trial Phase 2 study, sponsored by HealthPartners Institute.
NCT04028960 is a Phase 2 study that was terminated before completion, run by HealthPartners Institute. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028960, a Phase 2 study, was terminated before completion, sponsored by HealthPartners Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitoring (CGM) to collect this information. The study drug or placebo will be administered using an intranasal device.
Primary Outcome
Defined using percent time below range (\<54 mg/dL), from real-time continuous glucose monitoring (CGM)
Interventions
- DRUG Regular insulin (Humulin-R), intranasal route
- DEVICE SipNose intranasal device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-10-23 |
| Est. Completion | 2020-04-08 |
| Phase | Phase 2 |
Why NCT04028960 stopped before completion
NCT04028960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Regular insulin (Humulin-R), intranasal route is the first listed.
NCT04028960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04028960 about?
NCT04028960 is a clinical study titled "IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase". The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitori...
What is the current status of trial NCT04028960?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-10-23. Estimated completion is 2020-04-08.
What interventions are being tested in trial NCT04028960?
The interventions under investigation include: Regular insulin (Humulin-R), intranasal route (DRUG), SipNose intranasal device (DEVICE).
Who is sponsoring clinical trial NCT04028960?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04028960's enrollment target sits among peer trials
4 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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