Immunomodulatory Therapy for Recently Onset Type 1 Diabetes

Clinical Trial of Immunomodulatory Therapy Using Anti-Thymocyte Globulin and Pegfilgrastim for Recently Onset Type 1 Diabetes - CRITICAL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180089

Enrollment

Registered

2019-01-18

Start date

2019-08-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

We use anti-thymocyte globulin and pegfilgrastim, those were not used as standard therapies for type 1 diabetes, to evaluate the safety and efficacy for the treatment of recently onset type 1 diabetes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute-onset type 1 diabetes 2. Within 12 months since diagnosis 3. Fasting serum C-peptide > 0.3 ng/mL

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Pregnancy/breast-feeding 3. Past history of malignant tumor 4. Interstitial pneumonia 5. Severe liver or/and kidney dysfunction 6. Past history of ATG administration 7. Under systemic steroid therapy

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events during 52 weeks of the treatment or observation	—

Secondary

Measure	Time frame
1) Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 52 weeks of the treatment or observation 2) Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 104 weeks of the treatment or observation 3) Fasting plasma glucose 4) HbA1c 5) Glycated albumin 6) Fasting serum C-peptide 7) C-peptide index 8) Secretory Units of Islets in Transplantation (SUIT) 9) Mean Amplitude of Glycemic Excursions (MAGE) 10) Standard deviation (SD) of glucose levels evaluated with continuous glucose monitoring (CGM) 11) The percentages of glucose levels within normal range in CGM 12) The percentages of glucose levels above or below normal range in CGM 13) Total daily dose of insulin 14) The frequencies of severe hypoglycemia 15) Islet-related autoantibodies 16) T cell subsets measured by flow cytometry	—

Measure

Time frame

1) Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 52 weeks of the treatment or observation 2) Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 104 weeks of the treatment or observation 3) Fasting plasma glucose 4) HbA1c 5) Glycated albumin 6) Fasting serum C-peptide 7) C-peptide index 8) Secretory Units of Islets in Transplantation (SUIT) 9) Mean Amplitude of Glycemic Excursions (MAGE) 10) Standard deviation (SD) of glucose levels evaluated with continuous glucose monitoring (CGM) 11) The percentages of glucose levels within normal range in CGM 12) The percentages of glucose levels above or below normal range in CGM 13) Total daily dose of insulin 14) The frequencies of severe hypoglycemia 15) Islet-related autoantibodies 16) T cell subsets measured by flow cytometry

—

Contacts

Public ContactDAISUKE CHUJO

Toyama University Hospital

dchujo@med.u-toyama.ac.jp+81-76-434-2281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026