Lyumjev Insulin for Type 1 Diabetes

(Lpad Lyumjev Trial)

Overseen By Lianna Smith

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mark D. DeBoer, MD, MSc., MCR

Must be taking: Insulin

Must not be taking: Oral steroids, Non-insulin glucose-lowering

Disqualifiers: Diabetic ketoacidosis, Severe hypoglycemia, Seizure disorder, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a new insulin, Lyumjev, helps people with type 1 diabetes manage their blood sugar compared to Humalog or Novolog. Researchers aim to determine if Lyumjev can maintain blood sugar levels within the target range more effectively using a new method for setting insulin doses. The trial seeks participants who have had type 1 diabetes for at least a year, use the Tandem t:slim insulin pump, and are willing to try Lyumjev if selected. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management research.

Will I have to stop taking my current medications?

You will need to stop any non-insulin glucose-lowering medications, like metformin or GLP-1 agonists, before joining the trial. However, you must continue using insulin and may need to switch to Humalog or Novolog if you aren't using them already.

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

Research has shown that Lyumjev, a fast-acting insulin, is generally safe but can cause some side effects. The most common issue is hypoglycemia, or low blood sugar, which is typical with many insulin treatments.

Other possible side effects include skin reactions at the injection site, such as redness or itching. Some individuals might also notice changes in the fat under their skin, known as lipodystrophy, or experience allergic reactions like a rash.

These side effects can range from mild to more serious, but they are similar to those seen with other insulin treatments. If any side effects occur, it is important to consult a healthcare provider for management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Lyumjev insulin because it offers a potentially faster-acting option for managing Type 1 diabetes compared to standard insulins like Humalog and Novolog. Lyumjev is designed with a unique formulation that allows it to be absorbed more quickly into the bloodstream, which could help people achieve better blood sugar control, especially around meal times. This rapid absorption could improve the time-in-range for blood sugar levels, making diabetes management more efficient and possibly enhancing daily life for those with Type 1 diabetes.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research has shown that Lyumjev insulin helps people with type 1 diabetes control their blood sugar levels effectively. In this trial, participants will either use Lyumjev insulin with settings determined by an experimental conversion factor or continue using their home Humalog or Novolog with optimized insulin settings. One study found that people using Lyumjev had slightly lower average blood sugar levels compared to those using insulin lispro, a common insulin. This suggests that Lyumjev might help manage blood sugar more effectively. Additionally, only 1.7% of participants experienced severe low blood sugar over 13 weeks, indicating a good safety profile. Overall, these findings suggest that Lyumjev is a promising option for improving blood sugar control in type 1 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Mark DeBoer, MD

Principal Investigator

University of Virginia Center for Diabetes Technology

Are You a Good Fit for This Trial?

This trial is for adolescents with Type 1 Diabetes who are already using a Control-IQ insulin pump. Participants should be comfortable with the technology and have stable diabetes management. Specific details about inclusion or exclusion criteria were not provided.

Inclusion Criteria

HbA1c >6.5 - 12%

Access to internet and willingness to upload data as needed

Not currently known to be pregnant or breastfeeding (females)

Exclusion Criteria

Current HbA1c <6.5 or >12

Pregnancy or intent to become pregnant during the trial

I haven't had diabetic ketoacidosis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization

Participants undergo a physician-driven insulin optimization phase using their home Humalog or Novolog in the Control-IQ control group

Not specified

Baseline Control

Participants have a two-week baseline control phase to assess time-in-range on the optimized insulin settings

2 weeks

Randomized Treatment

Participants are randomized to either switch to Lyumjev insulin with settings determined by a conversion factor or remain on their home Humalog or Novolog for a two-week period

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lyumjev

Trial Overview The study tests how well Lyumjev insulin, adjusted by an experimental conversion factor, works in maintaining blood sugar levels within the target range (70-180 mg/dL) compared to standard insulins like Humalog or Novolog in a Control-IQ pump.

How Is the Trial Designed?

Group I: Lyumjev insulin using settings determined by experimental conversion factor Experimental Treatment 1 Intervention

All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then use Lyumjev insulin for a two-week period with insulin settings determined using the conversion factor.

Group II: Humalog or Novolog using optimized insulin settings Active Control 1 Intervention

All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then remain on their home Humalog or Novolog for a two-week period using the optimized insulin settings. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.

Who Is Running the Clinical Trial?

Mark D. DeBoer, MD, MSc., MCR

Lead Sponsor

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study involving 1008 patients, short-acting insulin lispro and regular insulin Humulin R showed similar effectiveness in controlling blood sugar levels and had comparable safety profiles, with no significant differences in hypoglycemia incidents.

After a year of continued lispro therapy, glycosylated hemoglobin (HbA1C) levels returned to baseline, indicating that while lispro was well tolerated in the short term, long-term efficacy may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. Daniels, AR., Bruce, R., McGregor, L.[2022]

Treatment with humulin insulins showed high clinical effectiveness in managing diabetes, as evidenced by decreased insulin doses, stable diabetes compensation, and a reduction in insulin antibodies.

Humulin insulins are preferred over iletin-II due to their low immunogenicity, which means they are less likely to provoke an immune response and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of highly purified Iletin-II-type porcine insulins and human insulin preparations in clinical practice]. Petunina, NA., Balabolkin, MI., Mkrtumian, AM., et al.[2011]

In a study of patients with type 1 diabetes, those using insulin glargine 300 U/mL (IG300) and insulin degludec (ID) showed similar long-term safety and efficacy compared to those continuing with insulin glargine 100 U/mL (IG100), with low rates of severe hypoglycemia and stable HbA1c levels over an average follow-up of 1.1 to 1.6 years.

Patients on IG100 experienced higher rates of severe adverse events and mortality (1.95%) compared to those on IG300 (0.7%) and ID (0.8%), suggesting that IG300 and ID may offer better safety profiles for long-term management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Treatment with New Basal Insulin Analogues in Type 1 Diabetes: Nation-Wide Survey. Svensson, AM., Ekelund, J., Miftaraj, M., et al.[2020]

In a phase 3 study involving 507 adults with type 1 diabetes, SAR342434 (SAR-Lis) demonstrated similar efficacy to insulin lispro-Humalog (Ly-Lis) in reducing HbA1c levels, confirming its noninferiority as a treatment option.

Both SAR-Lis and Ly-Lis showed comparable safety profiles, with no significant differences in hypoglycemic events, treatment-emergent adverse events, or immunogenicity over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Garg, SK., Wernicke-Panten, K., Rojeski, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38696672/

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with ... Results: The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05262387

A Study of LY900014 (Lyumjev) Versus Insulin Lispro ... This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy.

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/761109Orig1s000ClinPharmR.pdf

761109Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S) Converting to LYUMJEV from Other Insulins in Patients with Either Type 1 or Type 2 Diabetes. • If converting from another mealtime insulin to ...

4. pi.lilly.com pi.lilly.com/us/lyumjev-uspi.pdf

lyumjev-uspi.pdf No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571611/

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the ... Mean glucose on initialization of Boost was 232 ± 50 mg/dL with Lyumjev compared with 243 ± 50 mg/dL with insulin lispro (P = .48) and change in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/761109s000lbl.pdf

LYUMJEV (insulin lispro-aabc) - accessdata.fda.gov Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LYUMJEV. The rates of reported hypoglycemia depend on the ...

7. drugs.com drugs.com/sfx/lyumjev-side-effects.html

Lyumjev Side Effects: Common, Severe, Long Term Adverse reactions observed have included hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

8. healthline.com healthline.com/health/drugs/lyumjev-side-effects

Lyumjev: Side Effects and How to Manage Them Lyumjev (insulin lispro-aabc) can cause side effects ranging from mild to serious. More common side effects include rash and itching.

9. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/lyumjev

Lyumjev (previously Liumjev) - European Medicines Agency Over 6 months of treatment, patients with type 1 diabetes experienced a fall of 0.13 percentage points in HbA1c with Lyumjev and 0.05 percentage points with ...

10. medicalnewstoday.com medicalnewstoday.com/articles/drugs-lyumjev-side-effects

Lyumjev: Side effects and what to do about them As with other drugs, Lyumjev (insulin lispro-aabc) can cause side effects such as low blood sugar and burning at the injection site.