Clinical Trial Results:
A phase II randomized, placebo-controlled, double-blinded, 2-parallel arm, clinical trial evaluating Ladarixin 400 mg twice a day as adjunctive therapy to improve glycemic control in overweight insulin-resistant patients with type 1 diabetes
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Summary
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EudraCT number |
2022-000743-68 |
Trial protocol |
IT |
Global end of trial date |
18 Sep 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2026
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First version publication date |
01 Mar 2026
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Other versions |
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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 |
LDX0122
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05368402 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Dompé farmaceutici S.p.A.
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Sponsor organisation address |
Via Santa Lucia 6, Milano, Italy, 20122
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Public contact |
Clinical Trial Manager, Dompé farmaceutici S.p.A., +39 02583831, clinicaltrials@dompe.com
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Scientific contact |
Clinical Trial Manager, Dompé farmaceutici S.p.A., +39 02583831, clinicaltrials@dompe.com
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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 |
28 Nov 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Sep 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Sep 2023
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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 |
The primary objective of this clinical trial was to determine whether oral ladarixin versus placebo as adjunctive therapy is efficacious in improving glycemic control in overweight, insulin-resistant adult participants with type 1 diabetes.
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Protection of trial subjects |
Not Applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Sep 2022
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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 |
Italy: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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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) |
2
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The present study (CONSERVA) was a randomized, placebo-controlled, double-blind, 2-parallel arm, phase II trial and the study was conducted at two sites in Italy. | |||||||||
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Pre-assignment
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Screening details |
Of 24 participants who were screened, 21 failed to meet eligibility criteria, and 3 were enrolled, of which 2 were randomized: 1 in the IMP arm and 1 in the placebo arm. The third enrolled participant was not randomized after being enrolled due to study interruption. | |||||||||
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Period 1
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Period 1 title |
Overall Study (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, Data analyst, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ladarixin | |||||||||
Arm description |
Ladarixin was administered orally at the dose of 400 milligrams (mg) twice a day (b.i.d) for 7 cycles of 14 days with an interval of 14 days off, for a total duration of 26 weeks. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ladarixin
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Investigational medicinal product code |
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Other name |
LDX
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
The two daily oral doses of ladarixin (400 mg each dose) were administered at about a 12-hour interval (morning and evening; ideally between 6:30/11:30 and 18:30/23:30). At each administration, 2 capsules were swallowed with a glass of water, at least 2 hours apart from breakfast or dinner.
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Arm title
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Placebo | |||||||||
Arm description |
Matching placebo was administered with the same treatment schedule of the IMP. | |||||||||
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 |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was administered with the same schedule as Ladarixin.
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Baseline characteristics reporting groups
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Reporting group title |
Ladarixin
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Reporting group description |
Ladarixin was administered orally at the dose of 400 milligrams (mg) twice a day (b.i.d) for 7 cycles of 14 days with an interval of 14 days off, for a total duration of 26 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Matching placebo was administered with the same treatment schedule of the IMP. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ladarixin
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Reporting group description |
Ladarixin was administered orally at the dose of 400 milligrams (mg) twice a day (b.i.d) for 7 cycles of 14 days with an interval of 14 days off, for a total duration of 26 weeks. | ||
Reporting group title |
Placebo
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Reporting group description |
Matching placebo was administered with the same treatment schedule of the IMP. | ||
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End point title |
Number of Participants With an HbA1c Reduction From Baseline of ≥0.50% (Absolute Difference) Without Episodes of Severe Hypoglycemia [1] | ||||||||||||
End point description |
The primary endpoint was defined as the proportion of participant with an HbA1c reduction from baseline of ≥0.50% (absolute difference) without episodes of severe hypoglycemia at Week 27/28 (Visit 4). No efficacy evaluation was conducted due to the low recruitment rate (out of the 24 participants screened, only 2 participants were enrolled, 1 in the ladarixin group and 1 in the placebo group), resulting in a sample size not adequate for any formal statistical analyses. The low recruitment rate led the Sponsor decide to close enrollment on 04th August 2023 and thus to early terminate the study. No participants experienced an HbA1c reduction from baseline of at least ≥0.50%
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End point type |
Primary
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End point timeframe |
At Week 27/28 (Visit 4)
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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 applicable |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of participants With Treatment Emergent Adverse Events (TEAEs) of Any Kind From the Beginning of Study Treatment to up to the End of Study Participation | ||||||||||||
End point description |
This secondary endpoint was defined as the number of participants experiencing treatment emergent adverse events (TEAEs) of any kind from the beginning of study treatment administration to the end of study participation. An adverse event (AE) is any untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. A serious AE (SAE) was any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A non serious AE (nSAE) is any adverse drug experience associated with the use of the Product in humans, whether or not considered drug-related, which is not a SAE. TEAEs were defined as events with onset date or worsening during the on-treatment period.
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End point type |
Secondary
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End point timeframe |
Throughout the study, up to week 26 (day 182)
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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 |
Throughout the study up to week 26 (day 182), for the only 2 participants with safety results.
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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 |
25.0
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Reporting groups
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Reporting group title |
Ladarixin
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Reporting group description |
Ladarixin was administered orally at the dose of 400 mg b.i.d. for 7 cycles of 14 days with an interval of 14 days off, for a total duration of 26 weeks. | |||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Matching placebo was administered with the same treatment schedule of the IMP. | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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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: Not applicable |
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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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30 Jun 2022 |
- Study involved a more thorough definition of pregnancy and lactation as an exclusion criterion, implementation of safety checks at week 4 and end of the study, and a better definition of hypoglycemia |
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28 Oct 2022 |
- Refining the definition of detectable C-peptide to facilitate recruitment. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
| This study was terminated early due to low recruitment rates. | |||||||
