Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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⁃ To be eligible for the study, a subject must meet all of the following criteria:

• 18-60 years of age

• Clinical diagnosis of type 1 diabetes

• On insulin pump therapy and continuous glucose monitor for at least 3 months

• For females of childbearing potential, a negative pregnancy test and not attempting to conceive.

• Understanding and willingness to follow the protocol and sign informed consent

• Ability to speak, read and write English

Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Ryan Kingman, BS
rkingman@stanford.edu
650-736-4417
Backup
Alex Prossnitz, PhD
apross@stanford.edu
562-370-8779
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 20
Treatments
Experimental: Diluted Humalog U-200 Insulin
Participants will receive 0.20u/kg U-200 Humalog diluted 1:1 with sterile water, EDTA, and mannitol dilution buffer (final concentration U-100) through subcutaneous injection
Experimental: Diluted Humulin U-500 Insulin
Participants will receive 0.20u/kg U-500 Humulin diluted 1:4 with sterile water, EDTA, and mannitol dilution buffer (final concentration U-100) through subcutaneous injection
Active_comparator: Lyumjev U-100 Insulin
Participants will receive 0.20 u/kg commercially available U-100 Lyumjev insulin (unmodified) through subcutaneous injection.
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov