A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT02814838 |
Recruitment Status :
Completed
First Posted : June 28, 2016
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
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Sponsor:
Dompé Farmaceutici S.p.A
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Diabetes Mellitus, Insulin-Dependent |
Interventions |
Drug: Ladarixin Drug: Placebo |
Enrollment | 76 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Ladarixin | Placebo |
---|---|---|
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Ladarixin oral capsule Ladarixin: Ladarixin oral capsule |
Placebo oral capsule Placebo: Placebo oral capsule |
Period Title: Overall Study | ||
Started | 50 | 26 |
Completed | 48 | 25 |
Not Completed | 2 | 1 |
Reason Not Completed | ||
3 agreed dates for the final visit missed | 1 | 0 |
Consent withdrawal | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Ladarixin | Placebo | Total | |
---|---|---|---|---|
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Ladarixin oral capsule Ladarixin: Ladarixin oral capsule |
Placebo oral capsule Placebo: Placebo oral capsule |
Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 26 | 76 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 26 participants | 76 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
50 100.0%
|
26 100.0%
|
76 100.0%
|
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>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 26 participants | 76 participants | |
Female |
21 42.0%
|
10 38.5%
|
31 40.8%
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Male |
29 58.0%
|
16 61.5%
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45 59.2%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 26 participants | 76 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
1 2.0%
|
0 0.0%
|
1 1.3%
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White |
49 98.0%
|
26 100.0%
|
75 98.7%
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 26 participants | 76 participants |
Belgium | 20 | 11 | 31 | |
Italy | 17 | 10 | 27 | |
Germany | 13 | 5 | 18 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Pier Adelchi Ruffini, MD |
Organization: | Dompé Farmaceutici SpA |
Phone: | +39 02583831 |
EMail: | pieradelchi.ruffini@dompe.com |
Responsible Party: | Dompé Farmaceutici S.p.A |
ClinicalTrials.gov Identifier: | NCT02814838 |
Other Study ID Numbers: |
MEX0114 2014-003968-20 ( EudraCT Number ) |
First Submitted: | June 13, 2016 |
First Posted: | June 28, 2016 |
Results First Submitted: | November 16, 2020 |
Results First Posted: | January 12, 2021 |
Last Update Posted: | January 12, 2021 |