VC-02 for Type 1 Diabetes

Recruiting at 9 trial locations

Overseen By Corporate Communications

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ViaCyte

Disqualifiers: Transplants, Hypoglycemic events, Thyroid disease, Diabetic complications, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

49 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should have a stable diabetic treatment, which might mean you can continue your current regimen.

What data supports the effectiveness of the VC-02 drug for Type 1 Diabetes?

Research shows that adding liraglutide, a component similar to those in VC-02, to insulin treatment can improve blood sugar control and help with weight management in people with Type 1 Diabetes. ^{1 2 3 4 5}

How does the VC-02 treatment for Type 1 Diabetes differ from other treatments?

The VC-02 treatment is unique because it combines different components to potentially protect insulin-producing cells from immune system attacks and inflammation, which is not a standard approach in current Type 1 Diabetes treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests a new treatment that involves implanting a special product under the skin to help people with Type 1 Diabetes who can't sense low blood sugar. The goal is to see if this can help their bodies produce insulin naturally and manage blood sugar levels more effectively.

Research Team

Gautham Marigowda

Principal Investigator

Vice President, Clinical Development, Vertex

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with type 1 diabetes for at least five years.

You are physically suitable for a surgical implantation.

Only men and women who are not pregnant can participate.

Exclusion Criteria

Detectable stimulated serum C-peptide during screening period assessment.

You don't follow your current diabetes treatment plan.

Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VC-02 combination product implants and are monitored for safety and efficacy

26 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

• VC-02 Combination Product

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants.

Group II: Cohort 1 Experimental Treatment 1 Intervention

VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants

Who Is Running the Clinical Trial?

ViaCyte

Lead Sponsor

Trials

7

Recruited

200+

Vertex Pharmaceuticals Incorporated

Industry Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials

70

Recruited

3,300+

Horizon 2020 - European Commission

Collaborator

Trials

35

Recruited

14,200+

Findings from Research

In the Phase III DEFEND-2 trial involving 179 patients (including 54 adolescents), otelixizumab did not significantly preserve C-peptide secretion in patients with new-onset Type 1 diabetes, showing a change from baseline that was not statistically significant (P=0.051).

The study found that the efficacy and tolerability of otelixizumab at a 3.1 mg dose were similar to previous results from DEFEND-1, indicating that this dose was ineffective for both adults and adolescents, and further research is needed to explore higher doses and their mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study. Ambery, P., Donner, TW., Biswas, N., et al.[2018]

In a study of 50 children and adolescents with poorly controlled type 1 diabetes, switching to the IDegAsp insulin co-formulation led to a significant reduction in self-reported mild to moderate hypoglycemic episodes after one year.

While the overall hemoglobin A1c levels remained unchanged, the frequency of diabetic ketoacidosis (DKA) attacks decreased from 11 to 4, suggesting that IDegAsp may enhance clinical management for patients struggling with frequent hypoglycemia and DKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients Kırkgöz, T., Eltan, M., Kaygusuz, SB., et al.[2022]

In a 52-week study involving 1,398 adults with type 1 diabetes, adding liraglutide to insulin therapy significantly reduced HbA1c levels and insulin requirements, with reductions in body weight observed across all liraglutide doses compared to placebo.

However, the addition of liraglutide was associated with increased rates of symptomatic hypoglycemia and a significant rise in hyperglycemia with ketosis for the highest dose, which may limit its clinical use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Mathieu, C., Zinman, B., Hemmingsson, JU., et al.[2022]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Glycemic changes after vitamin D supplementation in patients with type 1 diabetes mellitus and vitamin D deficiency. [2022]

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

Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study. [2018]

3. Turkey pubmed.ncbi.nlm.nih.gov

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients [2022]

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

Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. [2022]

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

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. [2022]

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

Effects of combination therapy with dipeptidyl peptidase-IV and histone deacetylase inhibitors in the non-obese diabetic mouse model of type 1 diabetes. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

Effects of vitamin D repletion on glycemic control and inflammatory cytokines in adolescents with type 1 diabetes. [2016]

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

A potent immunomodulatory compound, (S,R)-3-Phenyl-4,5-dihydro-5-isoxazole acetic acid, prevents spontaneous and accelerated forms of autoimmune diabetes in NOD mice and inhibits the immunoinflammatory diabetes induced by multiple low doses of streptozotocin in CBA/H mice. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Combined Etanercept, GAD-alum and vitamin D treatment: an open pilot trial to preserve beta cell function in recent onset type 1 diabetes. [2022]

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

Immunomodulation for the prevention of SPIDDM and LADA. [2013]