ENC-201-CED for Type 1 Diabetes

Recruiting at 2 trial locations

Overseen By resCON Research

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Encellin

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 134 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ENC-201-CED for individuals with Type 1 diabetes. The main goal is to determine the treatment's safety and how well participants tolerate it when injected under the skin. Those eligible for islet cell infusions as part of their regular diabetes care might be suitable candidates for this study. For individuals with Type 1 diabetes who meet these criteria, this trial could be a valuable opportunity. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ENC-201-CED is likely to be safe for humans?

Research shows that ENC-201-CED is currently being tested for safety in people with Type 1 diabetes. In this early testing phase, the primary goal is to ensure it does not cause harmful effects. This phase identifies any side effects and assesses how the body responds to the treatment.

While specific safety data for ENC-201-CED is not yet available, treatments in this early phase undergo close monitoring for negative effects. The aim is to ensure safety before proceeding to further testing. Participants in this trial will be carefully monitored to gather comprehensive information about their reactions to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 1 Diabetes, which often involve insulin injections or pumps to manage blood sugar, ENC-201-CED is exciting because it targets the condition at the source. This treatment works by potentially modulating the immune system to preserve or restore the insulin-producing cells in the pancreas. Researchers are particularly interested in ENC-201-CED because it might reduce the need for frequent insulin administration and provide a more sustained, long-term solution for blood sugar regulation. This innovative approach could lead to improved quality of life for patients by addressing the root cause rather than just managing symptoms.

What evidence suggests that ENC-201-CED might be an effective treatment for Type 1 Diabetes?

Research has shown that ENC-201-CED is a new treatment being tested for Type 1 Diabetes in this trial. This experimental treatment aims to protect insulin-producing cells in the body, potentially improving blood sugar management. Although human studies provide limited information, the treatment might shield these cells from immune system attacks, a major issue in Type 1 Diabetes. Early results suggest this method could enhance blood sugar control, but further research is needed to confirm its effectiveness. ^{1 3 4 5 6}

Who Is on the Research Team?

Grace Wei, PhD

Principal Investigator

Encellin

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who meet the criteria for standard islet cell infusion therapy. It's not open to those who don't qualify for this standard treatment according to the site's specific rules.

Inclusion Criteria

I meet the requirements for islet cell transplant at my treatment center.

Exclusion Criteria

Candidates are excluded based on the site's criteria for standard of care islet infusion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ENC-201-CED in a subcutaneous space

134 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENC-201-CED

Trial Overview The study tests ENC-201-CED, a new intervention administered under the skin, to check its safety and how well patients can tolerate it in managing Type 1 Diabetes.

How Is the Trial Designed?

Group I: ENC-201-CED hPI Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Encellin

Lead Sponsor

Trials

1

Recruited

10+

resCON Research

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

The DCCT/EDIC study, involving 1,441 subjects with type 1 diabetes, has been crucial in understanding the long-term effects of intensive therapy on diabetes complications, providing extensive data over a 30-year period.

Future analyses from this ongoing study will explore critical areas such as the progression of microvascular complications, the impact of glycemic variability, and the long-term effects of intensive therapy on cognitive function, making it a vital resource for diabetes research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: summary and future directions. Gubitosi-Klug, RA.[2022]

SGLT inhibitors significantly improve glycemic control in type 1 diabetes patients by reducing fasting plasma glucose levels, glycated hemoglobin, and daily insulin doses, based on a meta-analysis of 13 randomized controlled trials involving 7,962 participants.

However, the use of SGLT inhibitors is associated with a higher risk of diabetic ketoacidosis and urinary and genital infections, although they do not increase the risk of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium-glucose cotransporter inhibitors as add-on therapy in addition to insulin for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. Zou, H., Liu, L., Guo, J., et al.[2023]

GLP-1 receptor agonists (like exenatide and liraglutide) can significantly lower hemoglobin A1C levels, plasma glucose, and body weight in patients with type 1 diabetes who are already on insulin, without increasing the risk of hypoglycemia.

The most common side effects of GLP-1 RAs are mild and transient gastrointestinal issues, making them a safe option for patients struggling with insulin side effects or those needing to lose weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Role of Glucagon-Like Peptide-1 Receptor Agonists in the Management of Type 1 Diabetes Mellitus. Harris, KB., Boland, CL.[2022]

Stem cell therapy significantly increased C-peptide levels and reduced glycated hemoglobin levels in patients with type 1 diabetes mellitus (T1DM), indicating improved insulin production and blood sugar control based on a meta-analysis of 22 studies.

The most effective outcomes were observed in patients aged 18 and older or those with a medical history of less than 3 months, particularly when higher doses of stem cells (≥107 IU/kg/day) were used, suggesting that patient characteristics and treatment protocols can influence the efficacy of stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell transplantation for the treatment of patients with type 1 diabetes mellitus: A meta-analysis. Gan, J., Wang, Y., Zhou, X.[2020]

The review highlights a growing need for effective therapies for type 1 diabetes (T1D), as currently, insulin is the only approved treatment, and many new drugs are in clinical development, including those with established and novel mechanisms of action.

New drug classes under investigation include SGLT inhibitors, GLP-1 agonists, and immunomodulatory drugs, with many compounds currently in Phase 1 and 2 trials, indicating a promising future for combination therapies that could enhance treatment options for T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. Mittermayer, F., Caveney, E., De Oliveira, C., et al.[2018]

Over a 10-year period, the SWEET registry showed significant improvements in hemoglobin A1C (HbA1c) levels in youth with type 1 diabetes, decreasing from 8.4% to 7.9%, indicating better blood sugar control.

The increase in the use of insulin pumps from 34% to 44% was linked to improved HbA1c target achievement, suggesting that advanced diabetes management technologies contribute to better outcomes in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SWEET Project 10-Year Benchmarking in 19 Countries Worldwide Is Associated with Improved HbA1c and Increased Use of Diabetes Technology in Youth with Type 1 Diabetes. Gerhardsson, P., Schwandt, A., Witsch, M., et al.[2022]

In a study of 151 patients with Type 1 diabetes who underwent continuous subcutaneous insulin infusion (CSII) for at least 5 years, the therapy significantly reduced the rate of severe hypoglycaemia from 0.66 to 0.17 episodes per patient per year (P < 0.001).

While CSII showed a transient reduction in HbA1c levels, with a notable improvement in patients with suboptimal metabolic control, the overall HbA1c reduction was not sustained after 5 years, indicating that while CSII is effective for hypoglycaemia, its long-term impact on glycaemic control may diminish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of insulin pump therapy: reduction of hypoglycaemia and impact on glycaemic control. Quirós, C., Giménez, M., Ríos, P., et al.[2018]

Type 1 diabetes affects about 370,000 adults in the UK and is characterized by the autoimmune destruction of insulin-producing beta cells, leading to a lack of insulin secretion without insulin resistance.

NICE guidelines recommend structured education for newly diagnosed patients within 12 months and suggest an optimal insulin regimen of twice daily long-acting insulin (detemir) combined with rapid-acting insulin at mealtimes to ensure effective self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the detection and management of type 1 diabetes. Hammond, P.[2016]

Sotagliflozin effectively lowers HbA1c levels in patients with type 1 diabetes mellitus (T1DM) without significantly increasing the risk of hypoglycemia, making it a promising option for better glycemic control.

However, the risk of diabetic ketoacidosis is notably higher with sotagliflozin, which means it should only be used in carefully selected patients who are well-informed and closely monitored by their healthcare provider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An up-to-date evaluation of sotagliflozin for the treatment of type 1 diabetes. Chatzopoulos, G., Tziomalos, K.[2022]

SGLT2 inhibitors significantly lower key diabetes markers in type 1 diabetes patients, including glycated hemoglobin (HbA1c) and fasting plasma glucose, while also reducing body weight and total insulin dosage, based on a meta-analysis of 16 randomized controlled trials involving 7192 patients.

Importantly, the use of SGLT2 inhibitors does not increase the risk of hypoglycemia, urinary tract infections, or diarrhea, suggesting they can be safely integrated into treatment regimens for type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. Nan, J., Wang, D., Zhong, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06408311

NCT06408311 | Safety of ENC-201-CED ENCRT Study Overview​​ The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.

2. trial.medpath.com trial.medpath.com/clinical-trial/19ea945276a2a804/nct06408311-safety-tolerability-study-enc-201-ced-type-1-diabetes

Safety of ENC-201-CED ENCRT | MedPath The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.

3. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-type-1-4-2024-48f0d

ENC-201-CED for Type 1 Diabetes This Phase 1 medical study run by Encellin is evaluating whether ENC-201-CED will have tolerable side effects & efficacy for patients with Diabetes Mellitus ...

4. trialx.com trialx.com/clinical-trials/listings/290400/safety-of-enc-201-ced-encrt/

Safety of ENC-201-CED ENCRT | Clinical Research Trial ... The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.

5. clinicaltrials.breakthrought1d.ca clinicaltrials.breakthrought1d.ca/

Breakthrough T1D - Clinical Trials A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With ...

6. ctv.veeva.com ctv.veeva.com/study/safety-of-enc-201-ced-encrt

Safety of ENC-201-CED ENCRT - ClinicalTrials.Veeva The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.