Curing Diabetes

Newly Diagnosed

Frexalimab in Preservation of Endogenous insulin Secretion Compared to Placebo in adults and Adolescents on Top of Insulin Therapy (FABULINUS)

The FABULINUS trial is recruiting patients with newly diagnosed type 1 diabetes, aged 12 to 35, to assess the efficacy of Frexalimab, a CD40L-antagonist monoclonal antibody, in preserving pancreatic beta cell function compared to a placebo.

Status: RECRUITING*

Population: Patients with T1D

Study Type: Interventional

  • 12-35 years of age
  • positive for ≥1 T1D autoantibody
  • initiated exogenous insulin replacement therapy not longer than 90 days prior to the screening visit

Intervention: Frexalimab, a CD40L-antagonist monoclonal antibody, for preservation of pancreatic beta cell function in adults and adolescents with newly diagnosed T1D.

Comparison: A placebo will be used as a comparator for the treatment period of this study.

Outcome: The primary outcome measure is the change from baseline to week 52 in mean 2-hour mixed meal tolerance test stimulated C-peptide concentration. The study will also investigate the effect on the proportion of participants with partial remission, the change from baseline in insulin dose and HbA1C level. The incidence of adverse events will be monitored throughout the study.

Timing: The treatment duration will be up to 104 weeks and the total study duration will be up to 135 weeks.

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT06111586

Contact:

Sponsor: Sanofi

*Status as of April 15, 2024, on https://clinicaltrials.gov.

A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed with T1D (DIAGNODE-3)

DIAGNODE-3 trial is recruiting patients aged 12 to 28 newly diagnosed with type 1 diabetes to investigate whether the study drug Diamyd, in combination with vitamin D3, can preserve insulin production and improve glycemic control in comparison with placebo.

Status: RECRUITING*

Study Type: Interventional

Population: Patients newly diagnosed with T1D

  • 12 -28 years of age
  • T1D diagnosis for ≤6 months
  • HLA DR3-DQ2 haplotype (all patients will be tested)
  • Fasting C-peptide ≥0.12 nmol/L (≥0.36 ng/mL) on at least one occasion
  • Detectable circulating GAD65 antibodies
  • HbA1c levels between 35 and 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization

Intervention: Diamyd (recombinant human glutamic acid decarboxylas formulated in Alhydrogel®) plus vitamin D3

Comparison: Placebo (alhydrogel® only) plus vitamin D3

Outcome: The primary outcome measures are change between baseline and month 24 in C peptide during a 2-hour mixed meal tolerance test and HbA1c.

Timing: The study duration will be two years

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT05018585

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Principal Investigator: Johnny Ludvigsson, Professor, Crown Princess Victoria Children´s Hospital and Linköping University

Sponsor: Diamyd Medical AB

*Status as of April 15, 2024, on https://clinicaltrials.gov.

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset T1D (TN25)

Study recruiting individuals aged 8 to 45 with newly diagnosed type 1 diabetes to evaluate the efficacy of combining rituximab-pvvr and abatacept compared to rituximab-pvvr alone, aiming to enhance the preservation of pancreatic function in participants.

Status: RECRUITING*

Study Type: Interventional

Population: Patients with new-onset T1D

  • 8 – 45 years of age
  • T1D diagnosis for ≤100 days
  • stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test conducted ≥21 days after diagnosis
  • positive for ≥1 T1D autoantibody

Intervention: All participants will receive rituximab-pvvr dosing from Week 1 to Week 4 of the trial. Participants in the active drug arm will receive initial abatacept dosing at Week 16 of trial. Abatacept will be given by a subcutaneous formulation weekly for 20 months.

Comparison: Participants in the placebo arm will receive initial placebo injection at Week 16 of trial. Saline Placebo will be given by a subcutaneous formulation weekly for 20 months.

Outcome: The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with abatacept after rituximab compared to those participants treated with rituximab and placebo 24 months after enrollment.

Timing: The study will continue for 4 years

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT03929601

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases

Collaborator: National Institutes of Health

Study Director: Kevan Herold, MD

*Status as of April 15, 2024, on https://clinicaltrials.gov.

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset T1D

This clinical trial is recruiting patients aged 12 to 35 with newly diagnosed type 1 diabetes to investigate the efficacy of Janus Kinase (JAK) inhibitors, specifically abrocitinib and ritlecitinib, in preserving pancreatic function compared to a placebo.

Status: RECRUITING*

Study Type: Interventional

Population: Patients with new-onset T1D

  • 12 – 35 years of age
  • T1D diagnosis for ≤100 days
  • stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test conducted ≥21 days after diagnosis
  • positive for ≥1 T1D autoantibody
  • HbA1c ≤ 10 %
  • Body weight ≥ 35kg at screening

Intervention: Two different JAK Inhibitors (abrocitinib and ritlecitinib) will be tested in subjects with recent onset Stage 3 T1D

Comparison: The JAK inhibitors will be compared to placebo treatment

Outcome: The primary outcome of interest is the difference between groups in the stimulated C-peptide following the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit.

Timing: 24 months

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT05743244

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases

Collaborator: Pfizer

*Status as of April 15, 2024, on https://clinicaltrials.gov.

Safety and Efficacy of CELZ-201 in Patients with Recent Onset T1D (CREATE-1)

CREATE-1 trial is recruiting patients aged 18 to 35 who were recently diagnosed with type 1 diabetes to assess the safety and efficacy of CELZ-201, a therapy derived from perinatal tissue cells, compared to standard diabetes care alone. This interventional study aims to evaluate the tolerability of a single dose of CELZ-201 administered alongside regular treatment over a 24-month period, focusing on the incidence of adverse events at the 6-month mark.

Status: RECRUITING*

Study Type: Interventional

Population: Patients with recent-onset T1D

  • 18 – 35 years of age
  • T1D diagnosis for ≤180 days
  • stimulated C-peptide peak level >0.6 ng/mL as assessed by 4-hour mixed meal tolerance test at screening.
  • positive for ≥2 T1D autoantibody

Intervention: Participants in this group will receive a single dose of CELZ-201, in addition to standard of care for T1D. CELZ-201 is prepared from Perinatal Tissue Derived Cells. These are cells that are harvested immediately before or after birth from umbilical cord blood and tissue from a single human donor source. The Perinatal Tissue Derived Cells used in this trial will come from a single donor mother, at the time of childbirth, who experienced a normal, non-complicated pregnancy.

Comparison: Participants in this group will receive standard of care for T1D only.

Outcome: The primary outcome to be assessed is tolerability and safety of the CELZ-201 therapy as assessed by the incidence of adverse events in both groups at 6 months.

Timing: The study will run for 24 months

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT05626712

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Sponsor: Creative Medical Technology Holdings Inc

Principal Investigator: Camillo Ricordi, MD, University of Miami, Diabetes Research Institute

*Status as of April 15, 2024, on https://clinicaltrials.gov.

Siplizumab in T1DM (DESIGNATE)

The DESIGNATE study is an interventional trial for patients aged 8 to 45 with recent-onset type 1 diabetes. This open-label, dose-finding study evaluates the impact of four different dosing regimens of siplizumab, administered separately to adults and children. The primary goal is to assess changes in immune, monitoring adverse events.

Status: ACTIVE BUT NOT RECRUITING*  

Study Type: Interventional

Population: Patients with recent-onset T1D

  • 8 – 45 years of age
  • T1D diagnosis within 18 months of enrolment
  • stimulated C-peptide peak level >0.15 pg/mL as assessed by a mixed meal tolerance test ≥21 days from diagnosis and within 37 days of enrollment.
  • ≥1 T1D autoantibody

Intervention: Four siplizumab dosing regimens in adults with T1D and four siplizumab dosing regimens in children with T1D.

Comparison: None- this is an open-label dose-finding study

Outcome: The primary outcome measure is the change in T cell phenotype from Week 0 to Week 12. Adverse events, C-Peptide following mixed-meal tolerance test and insulin use will also be investigated.

Timing:  Up to 52 weeks

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT05574335

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Study Chair: Stephen Gitelman, MD, University of California San Francisco, School of Medicine: Diabetes Center

Sponsor: National Institute of Allergy and Infectious Diseases

*Status as of April 15, 2024, on https://clinicaltrials.gov.

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