Comparing faster-acting monomeric insulin formulations with Lyumjev in adults with type 1 diabetes

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

This trial will see if two modified insulins (diluted Humalog and diluted U-500 Humulin treated with EDTA) act faster than Lyumjev in adults with type 1 diabetes.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT07090824 on ClinicalTrials.gov

What this trial studies

This is a randomized, crossover, single-dose pilot in which each participant receives three subcutaneous insulin injections in random order, separated by at least 48 hours. The three formulations are diluted U-200 Humalog, diluted U-500 Humulin with EDTA to remove zinc, and commercial U-100 Lyumjev, each given after a standardized mixed meal. Frequent blood samples are collected over six hours at each visit to measure pharmacokinetic parameters such as Tmax, Cmax, elimination half-life, and area under the curve. The study tests whether zinc chelation and reduced metacresol concentration increase monomer content and speed insulin action compared with current formulation.

Who should consider this trial

Good fit: Adults 18–60 years old with type 1 diabetes who use an insulin pump and continuous glucose monitor for at least three months and who are not pregnant or trying to conceive.

Not a fit: People who are pregnant or lactating, recently had diabetic ketoacidosis or severe hypoglycemia, do not use a pump/CGM, or who seek immediate therapeutic benefit should not expect direct clinical benefit from this pharmacokinetic pilot.

Why it matters

Potential benefit: If successful, these formulation changes could produce faster-acting insulin that improves meal-time glucose control and reduces the need for pre-meal dosing.

How similar studies have performed: Laboratory and early-phase work has shown that zinc removal and metacresol reduction can increase insulin monomers and speed action, but clinical evidence in people is limited and this approach remains early-stage.

Eligibility criteria

Inclusion Criteria:

To be eligible for the study, a subject must meet all of the following criteria:

1. 18-60 years of age
2. Clinical diagnosis of type 1 diabetes
3. On insulin pump therapy and continuous glucose monitor for at least 3 months
4. For females of childbearing potential, a negative pregnancy test and not attempting to conceive.
5. Understanding and willingness to follow the protocol and sign informed consent
6. Ability to speak, read and write English

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

1. Diabetic ketoacidosis within 3 months
2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
3. Have donated blood within 8 weeks
4. Have a known clinically significant history of anemia
5. Pregnant or lactating
6. Active infection
7. Any medical condition that, in the investigator's opinion, might interfere with study completion or participant safety.
8. Known seizure disorder
9. Inpatient psychiatric treatment within 6 months
10. Medication instability within 1 month prior to enrollment, including antihypertensive, thyroid, antidepressant, or lipid-lowering medications
11. Suspected drug or alcohol abuse
12. Chronic kidney disease (GFR \< 60 mL/min/1.73m²)

Where this trial is running

Palo Alto, California

• Stanford University — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Rayhan A Lal, MD — Stanford University
• Study coordinator: Ryan Kingman, BS

Conditions: Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus, T1D, Insulin-Dependent Diabetes Mellitus, Pharmacokinetics, Insulin, Subcutaneous Insulin, Drug: Insulin Lispro