Clinical Trial Results:
In vivo molecular imaging of angiogenesis in type 2 diabetes
Summary
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EudraCT number |
2019-003466-41 |
Trial protocol |
DK |
Global end of trial date |
06 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2022
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First version publication date |
01 Mar 2022
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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 |
AK2019-10
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Dr Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, rasmus.ripa@regionh.dk
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Scientific contact |
Dr Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, rasmus.ripa@regionh.dk
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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 |
15 Nov 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Oct 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Oct 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis in persons with type 2 diabetes compares to controls without diabetes.
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Protection of trial subjects |
The study investigated a new i.v. radiotracer for detecting angiogenesis. There were no discomfort or pain associated with the study of the new tracer.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jan 2020
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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 |
Denmark: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
24
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85 years and over |
0
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Recruitment
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Recruitment details |
The study population was recruited as a sub-group from the Rubin 2 (DOI: 10.1111/dme.14517) at a single center in Copenhagen, Denmark from January 23rd 2020 until October 5th 2020. | |||||||||
Pre-assignment
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Screening details |
48 persons, 29 with type 2 diabetes and 19 controls participated included in the Rubin 2 study (DOI: 10.1111/dme.14517) was screened for inclusion. All 48 screened persons were eligible for inclusion. However due to the Covid19 pandemic, inclusion had to be terminated in October 2020 after inclusion of 30 participants. | |||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Type 2 diabetes | |||||||||
Arm description |
The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
68Ga-NODAGA-E[c(RGDyK)]2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2
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Arm title
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Non-diabetic controls | |||||||||
Arm description |
The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
68Ga-NODAGA-E[c(RGDyK)]2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2
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Baseline characteristics reporting groups
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Reporting group title |
Type 2 diabetes
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Reporting group description |
The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Non-diabetic controls
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Reporting group description |
The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Type 2 diabetes
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Reporting group description |
The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point | ||
Reporting group title |
Non-diabetic controls
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Reporting group description |
The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point. |
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End point title |
Cardiac 68Ga-RGD uptake in type 2 diabetes and non-diabetic controls | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
cross section
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Statistical analysis title |
Primary endpoint | ||||||||||||
Comparison groups |
Type 2 diabetes v Non-diabetic controls
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
= 0.99 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [1] - We applied the Student’s t-tests for continuous variables to analyse differences in RGD uptake between the participants with type 2 diabetes and the non-diabetic controls. |
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Adverse events information
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Timeframe for reporting adverse events |
All participants were monitored 24 hours after injection of the radiotracer for adverse eventa.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Type 2 diabetes
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Reporting group description |
The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point | |||||||||||||||||||||||||||||||||||||||
Reporting group title |
Non-diabetic controls
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Reporting group description |
The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point. | |||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||
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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 study was planned to include all participants in the re-examination who gave consent to this sub-study, however due to the Covid19 pandemic, inclusion had to be terminated in October 2020 after inclusion of 30 participants. |