Clinical Trial Results:
Effects of Linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes
Summary
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EudraCT number |
2013-000330-35 |
Trial protocol |
AT |
Global end of trial date |
28 Apr 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2020
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First version publication date |
01 Jan 2020
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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 |
HS-2012-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02350478 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Graz
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Sponsor organisation address |
Auenbruggerplatz 2, Graz, Austria, 8010
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Public contact |
Harald Sourij, Medizinische Universität Graz, 0043 31638581310, ha.sourij@medunigraz.at
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Scientific contact |
Harald Sourij, Medical University of Graz, 0043 31638581310, ha.sourij@medunigraz.at
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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 |
13 Nov 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Apr 2018
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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 investigate the impact of a 12 week linagliptin treatment on endothelial function in patients with early type 2 diabetes.
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Protection of trial subjects |
All laboratory results will be reviewed and the reports signed by the study physician who will record whether it is normal, abnormal but not clinically significant, or abnormal and clinically significant. In the latter case, the eligibility of the subject will be reviewed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 May 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Austria: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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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) |
35
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From 65 to 84 years |
14
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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 49 randomizations were performed. After randomization, two subjects were excluded due to screening failures without receiving the study medication. Therefore 47 subjects were enrolled in the study and received the study medication. Of those, 3 subjects were lost to follow up without available follow-up data and 1 subject was excluded. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Investigator, Monitor, Subject, Carer | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Linagliptin | ||||||||||||||||||
Arm description |
Linagliptin 5mg /daily oral | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Linagliptin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
5mg oral daily
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Placebo | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
5mg daily oral
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Baseline characteristics reporting groups
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Reporting group title |
Linagliptin
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Reporting group description |
Linagliptin 5mg /daily oral | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Linagliptin
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Reporting group description |
Linagliptin 5mg /daily oral | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo |
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End point title |
Changes in Flow Mediated Dilatation | ||||||||||||
End point description |
Changes in Flow Mediated Dilatation from baseline to 12 weeks
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End point type |
Primary
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End point timeframe |
12 weeks
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Statistical analysis title |
Group comparison | ||||||||||||
Comparison groups |
Placebo v Linagliptin
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Changes in Global Arginine Bioavailability Ratio | ||||||||||||
End point description |
Changes in Global Arginine Bioavailability Ratio from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Arginine to Ornithine Ratio | ||||||||||||
End point description |
Changes in Arginine to Ornithine Ratio from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Soluble cell adhesion molecules-1 | ||||||||||||
End point description |
Changes in Soluble cell adhesion molecules-1 from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Soluble vascular cell adhesion molecule-1 | ||||||||||||
End point description |
Changes in Soluble vascular cell adhesion molecule-1 from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Area under curve for glucose | ||||||||||||
End point description |
Changes in Area under curve for glucose from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Change in Area under curve for free fatty acids | ||||||||||||
End point description |
Change in Area under curve for free fatty acids from baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Area under curve for insulin | ||||||||||||
End point description |
changes in Area under curve for insulin from baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Changes in Area under curve for c-peptide | ||||||||||||
End point description |
Changes in Area under curve for c-peptide from Baseline to 12 weeks
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End point type |
Secondary
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End point timeframe |
12 weeks
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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 |
12 weeks
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
Linagliptin
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Reporting group description |
Verum Group | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo group | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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05 Aug 2013 |
Combination of Screening and Baseline Visits |
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22 Oct 2013 |
Inclusion criterion (max age changed from 75 to 80 years) |
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30 Apr 2014 |
Exclusion criteria: HbA1c <6.0% (42mmol/mol) instead of HbA1c <6.5 (48mmol/mol) |
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24 Oct 2014 |
Storage of blood samples in the Biobank (Medical University of Graz) |
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29773079 http://www.ncbi.nlm.nih.gov/pubmed/27733180 |