Lyumjev Insulin for Type 1 Diabetes

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?

A randomized controlled trial of Control-IQ, assessing glycemic control (time-in-range 70-180 mg/dL) for Lyumjev insulin (in which the insulin settings have been determined using an experimental conversion factor) as compared to Humalog or Novolog (using optimized settings)

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 Lyumjev insulin safe for humans?

The safety of LY2963016 insulin glargine, which is similar to Lyumjev, has been studied in patients with type 1 and type 2 diabetes. These studies found no significant safety concerns, indicating it is generally safe for human use. ^{1 2 3 4 5}

How is Lyumjev insulin different from other insulin treatments for type 1 diabetes?

Lyumjev insulin is unique because it is designed to work faster than other insulins, helping to control blood sugar levels more quickly after meals. This rapid action can be beneficial for people with type 1 diabetes who need to manage their blood sugar spikes effectively. ^{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 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]

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 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Comparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus®) in Chinese patients with type 1 diabetes: A phase III, randomized, controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Treatment with New Basal Insulin Analogues in Type 1 Diabetes: Nation-Wide Survey. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of LY2963016 insulin glargine and Lantus® insulin glargine in Chinese patients with type 1 or type 2 diabetes mellitus. [2022]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type&#160;1 Diabetes Previously Treated with Insulin Glargine (Lantus&#174;): a Post Hoc Analysis of a Randomized, Open-Label, Phase&#160;3 Trial. [2022]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of highly purified Iletin-II-type porcine insulins and human insulin preparations in clinical practice]. [2011]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. [2022]