Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes
Stanford University
20 participants
Oct 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- To be eligible for the study, a subject must meet all of the following criteria:
- 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
Exclusion Criteria13
- The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis within 3 months
- Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- Have donated blood within 8 weeks
- Have a known clinically significant history of anemia
- Pregnant or lactating
- Active infection
- Any medical condition that, in the investigator's opinion, might interfere with study completion or participant safety.
- Known seizure disorder
- Inpatient psychiatric treatment within 6 months
- Medication instability within 1 month prior to enrollment, including antihypertensive, thyroid, antidepressant, or lipid-lowering medications
- Suspected drug or alcohol abuse
- Chronic kidney disease (GFR \< 60 mL/min/1.73m²)
Interventions
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.
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07090824