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NCT07090824 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes
A Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07090824: Recruiting Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, sponsored by Stanford University.
NCT07090824 is a Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus that is actively recruiting participants, run by Stanford University. The registered enrollment target is 20 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 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
NCT07090824, a Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The SPEED study is a randomized, crossover pilot study evaluating the pharmacokinetics of novel insulin formulations in adults with type 1 diabetes. The study compares two experimental insulin formulations (diluted U-200 Humalog and U-500 Humulin with sterile water, mannitol and EDTA) against commercially available U-100 Lyumjev to determine if these modifications can improve insulin onset and duration of action. Twenty participants will complete three study visits, each separated by at least48 hours. At each visit, participants will receive one of the three insulin formulations (0.20 u/kg) via subcutaneous injection following consumption of a standardized mixed meal. Blood samples will be collected frequently over 6 hours to measure insulin concentrations and assess pharmacokinetic parameters, including time to maximum concentration (Tmax), maximum concentration (Cmax), elimination half-life, and area under the curve. The study aims to address limitations of current insulin formulations used in automated insulin delivery systems, which are too slow to provide optimal meal coverage without pre-meal dosing. By reducing zinc content through EDTA chelation and decreasing metacresol concentration through dilution, these novel formulations may offer faster onset and shorter duration of action, potentially improving glucose control in people with type 1 diabetes using insulin pump therapy.
Primary Outcome
Time from insulin injection to maximum plasma insulin concentration for each insulin formulation, determined from frequent blood sampling data. Measured using validated enzyme-linked immunosorbent assay (ELISA).
Conditions Studied
Interventions
- DRUG Diluted Humalog U-200 Insulin
- DRUG Diluted U-500 Humulin Insulin
- DRUG Lyumjev U-100 Insulin
- DIETARY_SUPPLEMENT Boost Mixed Meal Test
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What NCT07090824 shows while recruiting
NCT07090824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 4 interventions - of which Diluted Humalog U-200 Insulin is the first listed.
NCT07090824 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07090824 about?
NCT07090824 is a clinical study titled "Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes". The SPEED study is a randomized, crossover pilot study evaluating the pharmacokinetics of novel insulin formulations in adults with type 1 diabetes. The study compares two experimental insulin formulations (diluted U-200 Humalog and U-500 Humulin with sterile water, mannitol and EDTA) against commer...
What is the current status of trial NCT07090824?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-10-28. Estimated completion is 2026-10.
What conditions does trial NCT07090824 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT07090824?
The interventions under investigation include: Diluted Humalog U-200 Insulin (DRUG), Diluted U-500 Humulin Insulin (DRUG), Lyumjev U-100 Insulin (DRUG), Boost Mixed Meal Test (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07090824?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07090824 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
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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 NCT07090824's enrollment target sits among peer trials
20 96th of 118 higher than 16 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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.
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