Clinical Trial Results:
A phase 4, monocenter, randomized, open label, comparator-controlled, parallel-group, mechanistic intervention trial to assess the effect of 8-week treatment with the glucagon-like peptide-1 receptor agonist lixisenatide versus insulin glulisine on renal physiology and biomarkers in insulin glargine-treated patients with type 2 diabetes mellitus
Summary
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EudraCT number |
2014-002178-35 |
Trial protocol |
NL |
Global end of trial date |
14 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Nov 2021
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First version publication date |
26 Nov 2021
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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 |
DC2014ELIX001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1151-0579 | ||
Sponsors
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Sponsor organisation name |
VU University Medical Center
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Sponsor organisation address |
De Boelelaan 1117, Amsterdam, Netherlands,
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Public contact |
Lennart Tonneijck, VU University Medical Center, 0031 0204440651, l.tonneijck@vumc.nl
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Scientific contact |
Lennart Tonneijck, VU University Medical Center, 0031 0204440651, l.tonneijck@vumc.nl
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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 |
21 Oct 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Aug 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Aug 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 |
Primary objective: To assess the long-term effects (i.e. after 8-week drug exposure) of the GLP-1RA lixisenatide versus insulin glulisine on renal hemodynamics (glomerular filtration rate/effective renal plasma flow) in patients with type 2 diabetes
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Protection of trial subjects |
n.a.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2014
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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 |
Netherlands: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
26
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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 |
51 patients were screened, 40 were included | ||||||||||||||||||
Period 1
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Period 1 title |
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 |
Subject, Investigator | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Lixisenatide | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
lixisenatide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
once daily 20 mcg
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Arm title
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Glulisine | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
insulin glulisine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
once daily at breakfast, starting at 2 units - titration towards glucose 5-8 2-hr after breakfast
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: One patient was included in the study, yet withdrew consent before randomisation |
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Baseline characteristics reporting groups
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Reporting group title |
Lixisenatide
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Glulisine
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lixisenatide
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Reporting group description |
- | ||
Reporting group title |
Glulisine
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Reporting group description |
- | ||
Subject analysis set title |
Kidney function
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Kidney function
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End point title |
Kidney function | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
full study
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Statistical analysis title |
GFR | ||||||||||||||||
Comparison groups |
Lixisenatide v Glulisine
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Number of subjects included in analysis |
35
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.989 | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
entire study
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
no dictionary used | |||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Glulisin
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Lixisenatide
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30353743 http://www.ncbi.nlm.nih.gov/pubmed/29915021 http://www.ncbi.nlm.nih.gov/pubmed/29341461 http://www.ncbi.nlm.nih.gov/pubmed/28449402 |