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NCT04545411 · ClinicalTrials.gov registry record · Phase 1
Combination GRA and SGLT-2i Treatment in Type 1 Diabetes
A Phase 1 study of Type 1 Diabetes, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04545411: Completed Phase 1 study of Type 1 Diabetes, sponsored by University of California, San Diego.
NCT04545411 is a Phase 1 study of Type 1 Diabetes that has completed, run by University of California, San Diego. The registered enrollment target is 12 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04545411, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
A pilot study for individuals with Type 1 Diabetes who are willing to add an SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor) in combination with placebo or a GRA (Glucagon Receptor Antagonist) to their current diabetes treatment regimen. There will be 15 study visits over approximately 14 weeks in this cross-over study design. Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and treatment "B" consists of an SGLT-2i + placebo for 4 weeks. All participants will complete both treatment "A" and treatment "B" with a 6-week washout period in between the treatments. Testing includes 3 insulin withdraw challenges, 3 muscle biopsies, 3 fat biopsies, 3 vascular ultrasounds along with blood collection and vitals.
Primary Outcome
The change from baseline in peak BHB production as measured by the insulin withdrawal challenge.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dapagliflozin 10 MG [Farxiga]
- DRUG REMD-477
Study Locations (1)
California
- UC San Diego Altman Clinical & Translational Research Institute - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 1 |
What the finished NCT04545411 record still lists
NCT04545411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04545411 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04545411 about?
NCT04545411 is a clinical study titled "Combination GRA and SGLT-2i Treatment in Type 1 Diabetes". A pilot study for individuals with Type 1 Diabetes who are willing to add an SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor) in combination with placebo or a GRA (Glucagon Receptor Antagonist) to their current diabetes treatment regimen. There will be 15 study visits over approximately 14 weeks i...
What is the current status of trial NCT04545411?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-02-22. Estimated completion is 2022-10-31.
What conditions does trial NCT04545411 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04545411?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin 10 MG [Farxiga] (DRUG), REMD-477 (DRUG).
Who is sponsoring clinical trial NCT04545411?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545411 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04545411's enrollment target sits among peer trials
12 176th of 198 higher than 19 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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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