ENC-201-CED for Type 1 Diabetes

Recruiting at 1 trial location

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

Trial Summary

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.

What data supports the effectiveness of the treatment ENC-201-CED for Type 1 Diabetes?

The research does not provide direct evidence for ENC-201-CED, but studies show that using insulin pumps and continuous glucose monitoring can improve blood sugar control in Type 1 Diabetes, which might suggest potential benefits for similar treatments. ^{1 2 3 4 5}

Is ENC-201-CED safe for humans?

The safety of ENC-201-CED specifically isn't mentioned, but similar treatments like SGLT inhibitors and GLP-1 receptor agonists for type 1 diabetes have been studied. These treatments generally show mild and temporary side effects, mostly related to the stomach, and are considered safe when used with insulin. ^{6 7 8 9 10}

What is the purpose of this 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.

Research Team

Grace Wei, PhD

Principal Investigator

Encellin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Long-term outcome of insulin pump therapy: reduction of hypoglycaemia and impact on glycaemic control. [2018]

2. United States 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. [2022]

3. United States 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. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Stem cell transplantation for the treatment of patients with type 1 diabetes mellitus: A meta-analysis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. [2023]

7. England pubmed.ncbi.nlm.nih.gov

An up-to-date evaluation of sotagliflozin for the treatment of type 1 diabetes. [2022]

8. Japan 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. [2023]

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

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

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. [2018]