Clinical Trial Results:
Subcutaneous versus intravenous basal insulin in non-critical hospitalized diabetic patients receiving total parenteral nutrition
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Summary
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EudraCT number |
2015-003954-42 |
Trial protocol |
ES |
Global end of trial date |
19 Feb 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Apr 2021
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First version publication date |
01 Apr 2021
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Other versions |
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Summary report(s) |
FPS-INSUPAR-2015-01 |
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 |
FPS-INSUPAR-2015-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundación Pública Andaluza Progreso y Salud
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Sponsor organisation address |
Parque Científico y Tecnológico Cartuja, Avda. Américo Vespucio, 15. Edificio S-2. 41092 Sevilla, Seville, Spain, 41092
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Public contact |
Unidad de Apoyo a Ensayos Clínicos, Fundación Pública Andaluza Progreso y Salud, 34 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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Scientific contact |
Unidad de Apoyo a Ensayos Clínicos, Fundación Pública Andaluza Progreso y Salud, 34 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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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 |
19 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Feb 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Feb 2019
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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 |
Analyze the degree of metabolic control achieved by a pattern of regular insulin in the stock of parenteral nutrition (PN) plus glargine subcutaneous insulin, compared to regular insulin in the stock of PN.
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Protection of trial subjects |
This trial should be conducted in accordance with the protocol following the sponsor's SOPs. The trial shall be conducted in accordance with the recommendations for Clinical Trials and Investigational Product Evaluation in humans, as contained in the Declaration of Helsinki, as revised at successive World Assemblies (WMA, 2013), and the current Spanish Clinical Trial Legislation (RD 1090/2015). The ICH-GCP standards (CPMP/ICH/135/95) will be followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2016
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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 |
Spain: 161
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Worldwide total number of subjects |
161
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EEA total number of subjects |
161
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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) |
31
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From 65 to 84 years |
117
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85 years and over |
13
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Recruitment
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Recruitment details |
- Adults (>18 years) - Diagnosed with diabetes mellitus. - Admitted to a non-intensive care hospital ward. - Who have an indication for total parenteral nutritional support (TPN, understood as that which covers more than 70% of the estimated daily parenteral requirements) and it is foreseen that they will require it for a minimum of 5 days. | |||||||||
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Pre-assignment
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Screening details |
- Adults (>18 years) - Diagnosed with diabetes mellitus. - Admitted to a non-intensive care hospital ward. - Who have an indication for total parenteral nutritional support (TPN, understood as that which covers more than 70% of the estimated daily parenteral requirements) and it is foreseen that they will require it for a minimum of 5 days. | |||||||||
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Period 1
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Period 1 title |
Recruitment and follow up
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Insulin glargine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Single-dose insulin glargine (basal component) + regular insulin within NPT (prandial component). Fifty percent of the total calculated insulin dose would be administered as regular insulin within the NPT bag. The other 50 % of the total calculated insulin dose would be administered as subcutaneous basal insulin (insulin glargine in unidose).
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Regular Insuline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Parenteral use
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Dosage and administration details |
Regular insulin within NPT (basal + prandial component). The total calculated insulin dose would be administered as regular insulin within the NPT bag.
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Period 2
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Period 2 title |
Data analysis
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Insulin glargine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Single-dose insulin glargine (basal component) + regular insulin within NPT (prandial component). Fifty percent of the total calculated insulin dose would be administered as regular insulin within the NPT bag. The other 50 % of the total calculated insulin dose would be administered as subcutaneous basal insulin (insulin glargine in unidose).
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Regular Insuline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Parenteral use
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Dosage and administration details |
Regular insulin within NPT (basal + prandial component). The total calculated insulin dose would be administered as regular insulin within the NPT bag.
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Baseline characteristics reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Experimental
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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End point title |
Degree of metabolic control [1] | ||||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Variability and hypoglycaemia [2] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [2] - 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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Patients with glucose <= 70 mg/dL [3] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [3] - 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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Patients with glucose < 54 mg/dL [4] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [4] - 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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Severe hypoglycaemia [5] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [5] - 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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Mean capillary glucose [6] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [6] - 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: Not all the required data is available. However, the final results report is attached, explaining the statistical analysis carried out. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Insulin dose | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the study
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Mean post-TPN blood glucose | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the study
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| No statistical analyses for this end point | ||||||||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the study
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19
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Reporting groups
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Reporting group title |
both groups
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Reporting group description |
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| 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: 112 non-serious adverse events were detected, but it is not specified exactly which ones. |
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| Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Jul 2016 |
- Updating of the regulations governing clinical trials from Royal Decree 223/2004 to Royal Decree 1090/2015.
- Addition of the protocol acceptance signature sheet by the principal investigator of each centre.
- Addition of new abbreviations.
- Updating of the study calendar.
- Modification of section 2.6 Research Ethics Committee that has assessed the trial.
- Change of Principal Investigator at the Hospital Universitario Severo Ochoa centre.
- Change of Principal Investigator at the Hospital Universitario Virgen de la Arrixaca.
- Modification of section 6.5 Withdrawal criteria and planned analysis of withdrawals and abandomisations.
- Modification of section 7.2 Safety assessment.
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18 Apr 2017 |
- Change of Principal Investigator at the Virgen del Rocío University Hospital.
- Elimination of the centre Hospital de Cabueñes.
- Modification of section 2.7 Trial duration.
- Modification of section 7.3 Trial conduct.
- Modification of the schedule of visits.
- Change of minimum starting dose from 0.3 to 0.2 IU/kg. |
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01 Jun 2017 |
- Enlargement of centres: inclusion of the centre "Hospital Universitario Central de Asturias". |
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26 Sep 2017 |
- Change of Principal Investigator at the Complejo Asistencial Universitario de León centre.
- Extension of the trial duration |
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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. | |||
| As we focus on people with non-critical type 2 diabetes mellitus we cannot apply the conclusions to another group of patients. The sample size was calculated to detect differences in mean capillary glucose but not in complications. | |||
