NCT07090824CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 10 (actual)
First submitted: 21 Jul 2025
Start date: 28 Oct 2025
Primary completion date: 29 May 2026
Lead sponsor: Stanford University
Diseases: Type 1 diabetes
NCT number: NCT07090824

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 10
From 28 Oct 2025 to the primary completion date, 29 May 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
Medication instability within 1 month prior to enrollment, including antihypertensive, thyroid, antidepressant, or lipid-lowering medications
Suspected drug or alcohol abuse

Other illness

Have a known clinically significant history of anemia
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

Lab values

Chronic kidney disease (GFR \< 60 mL/min/1.73m²)

Other

The presence of any of the following is an exclusion for the study:
Diabetic ketoacidosis within 3 months
Have donated blood within 8 weeks
Pregnant or lactating

Who the study is looking for

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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Stanford University Coordinator of this site? Confirm its status	Palo Alto	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.