Clinical Trial Results:
GLYcemic Control with EMpagliflozin vs standard of care in patients with type 2 dIAbetes and Heart failure: effects on cardiac remodeling and neurohormonal activation
Summary
|
|
EudraCT number |
2018-000832-82 |
Trial protocol |
IT |
Global end of trial date |
07 Apr 2022
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
15 Dec 2022
|
First version publication date |
15 Dec 2022
|
Other versions |
|
Summary report(s) |
Final report_2018-000832-82 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
GLYCEMIA-Heart
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Fondazione Toscana Gabriele Monasterio
|
||
Sponsor organisation address |
Via g moruzzi, Pisa, Italy,
|
||
Public contact |
U.O.C. Farmaceutica Ospedaliera, Fondazione Toscana Gabriele Monasterio, +39 0585493507, farmacisti@ftgm.it
|
||
Scientific contact |
U.O.C. Farmaceutica Ospedaliera, Fondazione Toscana Gabriele Monasterio, +39 0585493507, farmacisti@ftgm.it
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
28 Oct 2022
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
07 Apr 2022
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
Test the effects of empagliflozin on neuro-hormonal activation, as exstimated by 1-year variation in NT-proBNP plasma concentrations
|
||
Protection of trial subjects |
The study protocol was evaluated and approved by the local Ethics Committee (CEAVNO) and by the Competent Authority, or the Italian Medicines Agency (AIFA). The study was performed in accordance with the Helsinki Declaration. The willingness of each individual patient to participate in the study was respected and informed consent was requested from each patient at the time of enrollment. The study was performed in accordance with the rules of Good Clinical Practice (GCP). No discrimination was applied in the enrollment of patients in terms of ethnicity, sexual, religious or political orientation. Sensitive data relating to enrolled patients will be kept for 7 years and will be used anonymously according to an alphanumeric coding.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2018
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Italy: 5
|
||
Worldwide total number of subjects |
5
|
||
EEA total number of subjects |
5
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
5
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
The GLYCEMIA-Heart study has been prematurely interrupted given the very low enrollment rate, and no relevant results could be obtained. The main reasons for such a low recruitment have been identified in the stringent enrollment criteria and, at least in the last 2 years, to the COVID-19 pandemics. | ||||||
Pre-assignment
|
|||||||
Screening details |
The GLYCEMIA-Heart study has been prematurely interrupted given the very low enrollment rate, and no relevant results could be obtained. The main reasons for such a low recruitment have been identified in the stringent enrollment criteria and, at least in the last 2 years, to the COVID-19 pandemics. | ||||||
Period 1
|
|||||||
Period 1 title |
treatment (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
treatment | ||||||
Arm description |
empagliflozin, a sodium-glucose cotransporter inhibitor | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
empagliflozin
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Tablet
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
1 tablet 10mg once a day
|
||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
treatment
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The GLYCEMIA-Heart study has been prematurely interrupted given the very low enrollment rate, and no relevant results could be obtained. The main reasons for such a low recruitment have been identified in the stringent enrollment criteria and, at least in the last 2 years, to the COVID-19 pandemics. Moreover, recent international indications have supported the use of SGLT2i in patients with heart failure and reduced ejection fraction, thus limited the possible pool of eligible patients and raising an ethical issue related to the allocation of a subgroup of patients to the “noempagliflozin arm”. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
treatment
|
||
Reporting group description |
empagliflozin, a sodium-glucose cotransporter inhibitor | ||
Subject analysis set title |
Final report_2018-000832-82
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The GLYCEMIA-Heart study has been prematurely interrupted given the very low enrollment rate, and no relevant results could be obtained. The main reasons for such a low recruitment have been identified in the stringent enrollment criteria and, at least in the last 2 years, to the COVID-19 pandemics. Moreover, recent international indications have supported the use of SGLT2i in patients with heart failure and reduced ejection fraction, thus limited the possible pool of eligible patients and raising an ethical issue related to the allocation of a subgroup of patients to the “noempagliflozin arm”.
|
|
|||||||||||
End point title |
Test the effects of empagliflozin on neuro-hormonal activation, as exstimated by 1-year variation in NT-proBNP plasma concentrations. [1] | ||||||||||
End point description |
Test the effects of empagliflozin on neuro-hormonal activation, as exstimated by 1-year variation in NT-proBNP plasma concentrations.
|
||||||||||
End point type |
Primary
|
||||||||||
End point timeframe |
1 year
|
||||||||||
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: The GLYCEMIA-Heart study has been prematurely interrupted given the very low enrollment rate, and no relevant results could be obtained. The main reasons for such a low recruitment have been identified in the stringent enrollment criteria and, at least in the last 2 years, to the COVID-19 pandemics. Moreover, recent international indications have supported the use of SGLT2i in patients with heart failure and reduced ejection fraction, thus limited the possible pool of eligible patients. |
|||||||||||
|
|||||||||||
No statistical analyses for this end point |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
no SAE during all the study
|
||
Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
5
|
||
Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: no SAE registered |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |