UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027070 |
|---|---|
| Receipt number | R000031003 |
| Scientific Title | Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2024/10/24 09:31:48 |
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Basic information
Public title
Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Acronym
Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Scientific Title
Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Scientific Title:Acronym
Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of immunomodulatoly therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of adverse events during 52 weeks of the treatment or observation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anti-thymocyte globulin: 0.5 mg/kg (Day 1), 1.5
mg/kg (Day 2)
Interventions/Control_2
Pegfilgrastim: 3.6 mg x 6 times every 2 weeks (starting at Day 3)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Acute-onset type 1 diabetes
2. Within 12 months since diagnosis
3. Fasting serum C-peptide > 0.3 ng/mL
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Chujo |
Organization
Toyama University Hospital
Division name
Center for Clinical Research
Zip code
930-0194
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-2281
dchujo@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Chujo |
Organization
Toyama University Hospital
Division name
Center for Clinical Research
Zip code
930-0194
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-2281
Homepage URL
dchujo@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Japan IDDM Network
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs031180089
Publication of results
Published
Result
URL related to results and publications
https://diabetesjournals.org/diabetes/article/72/Supplement_1/298-OR/150443/298-OR-Safety-and-Effica
Number of participants that the trial has enrolled
12
Results
In terms of safey, No grade 4 and 5 adverse events were reported in both treatment group (Tx) and control group (Ctrl). In terms of efficacy, the number of patients with %decline of C-peptide AUC (CPR-AUC) less than median during 52 weeks of study period were tended to be lower in the treatment group (P=0.067). Changes in HbA1c, glycated albumin, and daily insulin doses in 52 weeks and 104 weeks of observation were not significantly different between the two groups.
Results date posted
| 2024 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the treatment group and control group, the numbers of male/female were 3/3 and 4/2, age was 35.3 years and 40.5 years, disease duration was 4.2 months and 8.3 months, BMI was 21.4 kg/m2 and 19.0 kg/m2, HbA1c levels were 6.83%, 6.45%, fasting serum C-peptide concentrations were 1.03 ng/mL, 0.77 ng/mL, respectively (all values were expressed as mean).
Participant flow
Twelve patients, with the age>20 years, T1D duration<12 months, and serum CPR>0.3 ng/ml, were randomized into the ATG/PEG group (A/P; n = 6) and control group (Ctrl; n = 6). The A/P was administered 2.0 mg/kg ATG and six times of 3.5 mg PEG.
Adverse events
No severe adverse evetns related to the trial were reported.
Outcome measures
Primary outcome:
Frequency of adverse events during 52 weeks of the treatment or observation
Secondary outcomes:
Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 52 weeks of the treatment or observation
Changes in the AUC of C-peptide level evaluated with mixed-meal tolerance test during 104 weeks of the treatment or observation
HbA1c
Glycated albumin
Fasting serum C-peptide
Secretory Units of Islets in Transplantation (SUIT)
Total daily dose of insulin
The frequencies of severe hypoglycemia
T cell subsets measured by flow cytometry etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031003
