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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07090824
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Diluted Humalog U-200 Insulin — DRUG
    Commercially available U-200 Humalog (insulin lispro) diluted 1:1 with a dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.
  • Diluted U-500 Humulin Insulin — DRUG
    Commercially available U-500 Humulin (regular insulin) diluted 1:4 with dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.
  • Lyumjev U-100 Insulin — DRUG
    Commercially available U-100 Lyumjev (insulin lispro-aabc) administered unmodified as comparator. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.
  • Boost Mixed Meal Test — DIETARY_SUPPLEMENT
    Standardized mixed meal (Boost drink) administered at 8.0 mL/kg body weight (17.3 g carbohydrates per 100 mL) consumed immediately before insulin injection at each visit.

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Time to Maximum Insulin Concentration (Tmax) [ Time Frame: 0 to 360 minutes post-injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Ryan Kingman Kingman, BS
[email protected]
650-736-4417
Rayhan Lal, M.D.
[email protected]

Find similar trials in Palo Alto, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Stanford University· Palo Alto, CA

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