Clinical Trial Results:
DIAGNODE-B, A Phase I/II Open Label Pilot Study to evaluate the safety and feasibility of an additional intralymphatic booster administration of GAD-alum (Diamyd®) in individuals with Type 1 diabetes
Summary
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EudraCT number |
2021-005441-32 |
Trial protocol |
SE |
Global end of trial date |
29 Aug 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
12 May 2024
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First version publication date |
12 May 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DIAGNODE-B
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05351879 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Linköping University
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Sponsor organisation address |
Crown Princess Victoria Children´s Hospital and Div of Pediatrics, Department of Biomedical and Cli, Linköping, Sweden, 58183
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Public contact |
Johnny Ludvigsson, Linköping University, Johnny.Ludvigsson@liu.se
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Scientific contact |
Johnny Ludvigsson, Linköping University, Johnny.Ludvigsson@liu.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Mar 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Aug 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Aug 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to evaluate feasibility and safety of administering an additional intralymphatic booster dose of Diamyd.
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Protection of trial subjects |
After the injection of Diamyd each trial participant was to remain at the study clinic for at least 1 h and monitored by the study personnel.
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Background therapy |
All patients was to continue to receive standard of care treatment for Type 1 diabetes during the study. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Dec 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 6
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Worldwide total number of subjects |
6
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EEA total number of subjects |
6
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
5
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
In total, 6 patients (2 from the DIAGNODE-1 cohort and 4 from the DIAGNODE-2 cohort) were screened for the study and all met the eligibility criteria and were enrolled in the study. | ||||||
Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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ALUM-rhGAD65 + Vitamin D | ||||||
Arm description |
All patients received one dose of Diamyd 4 μg as a 0.1 mL intralymphatic injection into an inguinal lymph node. Vitamin D (cholecalciferol 2000 IE) was administered as tablets 2000 IU daily. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Diamyd
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Investigational medicinal product code |
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Other name |
ALUM-rhGAD65
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
GAD-alum (Diamyd®; 4 μg) was administered as a 0.1 mL intralymphatic injection into an inguinal lymph node.
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Investigational medicinal product name |
Vitamin D
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Investigational medicinal product code |
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Other name |
Caliciferol
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Commercially available vitamin D (cholecalciferol; trade name Divisun® 2000 IE) was administered as tablets 2000 IU daily.
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Period 2
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Period 2 title |
Overall Study
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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ALUM-rhGAD65 + Vitamin D | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Diamyd
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Investigational medicinal product code |
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Other name |
ALUM-rhGAD65
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
GAD-alum (Diamyd®; 4 μg) was administered as a 0.1 mL intralymphatic injection into an inguinal lymph node.
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Investigational medicinal product name |
Vitamin D
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Investigational medicinal product code |
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Other name |
Caliciferol
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Commercially available vitamin D (cholecalciferol; trade name Divisun® 2000 IE) was administered as tablets 2000 IU daily.
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ALUM-rhGAD65 + Vitamin D
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Reporting group description |
All patients received one dose of Diamyd 4 μg as a 0.1 mL intralymphatic injection into an inguinal lymph node. Vitamin D (cholecalciferol 2000 IE) was administered as tablets 2000 IU daily. | ||
Reporting group title |
ALUM-rhGAD65 + Vitamin D
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Reporting group description |
- |
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End point title |
Injection site reactions [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
From enrollment up to 1 year after the booster injection
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Too few patients and no comparator arm to enable statistical analysis. |
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No statistical analyses for this end point |
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End point title |
Change in C-peptide (AUCmean 0-120 min) during MMTT from baseline to 12 months | ||||||||
End point description |
Change ratio
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End point type |
Secondary
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End point timeframe |
Change from baseline to 12 months
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No statistical analyses for this end point |
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End point title |
Change in HbA1c from baseline to 12 months | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to month 12
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No statistical analyses for this end point |
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End point title |
Change in daily exogenous insulin consumption from baseline to 12 months | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to month 12
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No statistical analyses for this end point |
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End point title |
Change in IDAA1C (Insulin-dose-adjusted HbA1c levels) from baseline to 12 months | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to month 12
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No statistical analyses for this end point |
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End point title |
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) from baseline to 12 months | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to month 12
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No statistical analyses for this end point |
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End point title |
Change in time in hyperglycemic range > 10 mmol/L (> 180 mg/dL) from baseline to 12 months | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to month 12
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From enrollment up to 1 year after the booster injection.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26
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Reporting groups
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Reporting group title |
ALUM-rhGAD65 + Vitamin D
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Reporting group description |
All patients received one dose of Diamyd 4 μg as a 0.1 mL intralymphatic injection into an inguinal lymph node. Vitamin D (cholecalciferol 2000 IE) was administered as tablets 2000 IU daily. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The main limitation of the present pilot study is the low number of participants, and the results obtained herein, especially the efficacy results, should therefore be taken with caution. |