Insulin Formulations for Type 1 Diabetes

(SPEED Trial)

Overseen By Alex Prossnitz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must be taking: Insulin

Must not be taking: Antidepressants, Antihypertensives, others

Disqualifiers: Seizure disorder, Anemia, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 visits, each separated by at least 48 hours

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new insulin formulations for people with type 1 diabetes to determine if they work faster and have a shorter duration. Researchers aim to discover if these formulations can better manage blood sugar levels during meals when using an insulin pump. Participants will try three different insulin types—Diluted Humalog U-200 Insulin, Diluted U-500 Humulin Insulin, and Lyumjev U-100 Insulin—each at separate visits, to compare their performance. The study seeks adults with type 1 diabetes who have used an insulin pump and a continuous glucose monitor for at least three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive these new insulin formulations.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that medication instability within 1 month prior to enrollment is an exclusion. This suggests that your current medications should be stable before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both U-200 Humalog and U-500 Humulin have been tested for safety and effectiveness in people with diabetes. Studies have found that U-200 Humalog is a good option for those who need a lot of insulin. It has been used safely in automated insulin delivery systems and helps reduce daily insulin requirements without causing major side effects.

For U-500 Humulin, research indicates it can improve blood sugar control without greatly increasing the risk of low blood sugar. Some studies noted small increases in low blood sugar episodes, but overall, it is considered safe.

This trial is in its early stages, so the researchers are still collecting safety data. However, existing research on similar products suggests they are likely to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these insulin formulations for type 1 diabetes because they offer innovative variations in insulin concentration and delivery. Unlike standard insulins, the Diluted Humalog U-200 and Diluted Humulin U-500 are modified to a final concentration of U-100 using a unique dilution process with sterile water, EDTA, and mannitol, potentially allowing for more tailored dosing and absorption. Meanwhile, Lyumjev U-100 offers a rapid-acting insulin option that could improve post-meal blood sugar control. These treatments aim to provide more flexibility and potentially better glucose management than existing options.

What evidence suggests that this trial's insulin formulations could be effective for type 1 diabetes?

Research has shown that U-200 Humalog, one of the treatments in this trial, can help people with type 1 diabetes better control their blood sugar and reduce episodes of low blood sugar when used in automated insulin delivery systems. Participants receiving Diluted Humalog U-200 Insulin may experience more time with their blood sugar levels in the target range, indicating improved management.

Another treatment in this trial, U-500 Humulin, has also improved blood sugar control without greatly increasing the risk of low blood sugar. Participants receiving Diluted U-500 Humulin Insulin may see better adherence to treatment and improved blood sugar levels, although some may experience more low blood sugar events.

Both types of insulin in this trial are designed to work faster and for a shorter time, potentially helping people with type 1 diabetes manage their blood sugar more effectively, especially around meals. ^{1 2 4 6 7}

Who Is on the Research Team?

Rayhan A Lal, MD

Principal Investigator

Stanford University

Eric Appel, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Adults aged 18-60 with type 1 diabetes, using an insulin pump and continuous glucose monitor for at least 3 months. Participants must understand English, be willing to follow the study protocol, and not be pregnant or trying to conceive.

Inclusion Criteria

I understand the study and agree to follow its rules.

I can speak, read, and write in English.

I am between 18 and 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the three insulin formulations via subcutaneous injection following a standardized mixed meal. Blood samples are collected frequently over 6 hours to measure insulin concentrations.

3 visits, each separated by at least 48 hours

3 visits (in-person)

Follow-up

Participants are contacted 1-2 days after each visit to assess for unusual hypoglycemic or hyperglycemic episodes.

1-2 days after each visit

What Are the Treatments Tested in This Trial?

Interventions

• Diluted Humalog U-200 Insulin
• Diluted U-500 Humulin Insulin
• Lyumjev U-100 Insulin

Trial Overview The SPEED study is testing two experimental insulin formulations (diluted U-200 Humalog and U-500 Humulin) against a standard U-100 Lyumjev in adults with type 1 diabetes. It aims to see if these new formulas can act faster and last for a shorter time after meals.

How Is the Trial Designed?

Group I: Diluted Humulin U-500 Insulin Experimental Treatment 2 Interventions

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

Group II: Diluted Humalog U-200 Insulin Experimental Treatment 2 Interventions

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

Group III: Lyumjev U-100 Insulin Active Control 2 Interventions

Participants will receive 0.20 u/kg commercially available U-100 Lyumjev insulin (unmodified) through subcutaneous injection.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462802/

Real-World Safety and Effectiveness of U200 Insulin Use in ... These data suggest that U200-AID is a viable option for individuals with T1D and high insulin requirements.

2. liebertpub.com liebertpub.com/doi/abs/10.1177/15209156251359167

Real-World Safety and Effectiveness of U200 Insulin Use in ... Among 50 AYAs initiating U200-AID (age 15.4 years, T1D duration 5.5 years, hemoglobin A1c 8.5%), time in range (70–180 mg/dL) increased (44.6% ± 12.6% vs. 48.9% ...

3. diabetesjournals.org diabetesjournals.org/clinical/article/43/3/449/157975/Safe-and-Effective-Use-of-U-200-Insulin-With

Safe and Effective Use of U-200 Insulin With Automated ... Patients experienced improved glucose control, had less frequent hypoglycemia, and maintained their AID system in automated mode. Switching to U ...

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1692589/full

Practical considerations for using concentrated U200 ... Although the TIR goal of ≥70% was not reached, TIR improved from 44.6% to 48.9% despite no significant change in the number of user-initiated boluses per day.

5. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.221

Bioequivalence and comparative pharmacodynamics of ... In summary, the IL200 formulation was bioequivalent to the IL100 formulation (Humalog) after subcutaneous administration of 20 U to healthy ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2376060520301668

A Pediatric Case of Insulin Lispro U-200 as Continuous ... Results: After initiation of insulin lispro U-200, the patient was able to reduce the volume of insulin injection per day. Hemoglobin A1c decreased from 7.2 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf

Humalog - accessdata.fda.gov Intravenous Administration of HUMALOG U-100 — The glucose lowering effect of intravenously administered. HUMALOG was tested in 21 patients with type 1 diabetes.