Immunomodulatory Therapy for Recently Onset Type 1 Diabetes

Phase 1

• Conditions: Type 1 diabetes

• Registration Number: JPRN-jRCTs031180089
• Lead Sponsor: CHUJO DAISUKE

Brief Summary

We evaluated the safety and efficacy of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes. In terms of safety, no grade 4 and 5 severe adverse events were observed. In terms of efficacy, although some analyses showed potantial effects for the preservation of endogenous insulin secretion, the results were not significant. In the future, the efficacy of the treatment should be validated in the trial with more ceses.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-18
• Study Completion: 2022-06-10
• Results First Posted: 2023-06-23
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events during 52 weeks of the treatment or observation

Secondary Outcome Measures

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