Trial Outcomes & Findings for Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes. (NCT NCT05368402)

Last Updated: 2025-02-03

Results Overview

Please note that this outcome is meant to express the "count" (number + %) of participants. Please also note that because of 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), it was not possible to have a consistent sample size for any formal statistical analyses, accordingly no efficacy evaluation was conducted on the two randomized subjects' data. The low recruitment rate led the Sponsor decide to close enrollment on 04th August 2023 and thus to early terminate the study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

At Visit 4 (week 27/28)

Results posted on

2025-02-03

Participant Flow

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 by the sponsor.

Participant milestones

Participant milestones
Measure	Ladarixin 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. Ladarixin: 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	Placebo Matching placebo was administered with the same treatment schedule of the IMP. Placebo: Placebo was administered with the same ladarixin schedule.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ladarixin n=1 Participants 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. Ladarixin: 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	Placebo n=1 Participants Matching placebo was administered with the same treatment schedule of the IMP. Placebo: Placebo was administered with the same ladarixin schedule.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Italy	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: At Visit 4 (week 27/28)

Population: There were only two participants recruited in the study e.g., 1 in the Ladarixin group and 1 in the placebo group. Due to the low recruitment rate, the Sponsor decided to close enrollment on 04th August 2023 and thus to early terminate the study. Accordingly, Population consists of the two randomized participants only.

Outcome measures

Outcome measures
Measure	Ladarixin n=1 Participants 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. Ladarixin: 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	Placebo n=1 Participants Matching placebo was administered with the same treatment schedule of the IMP. Placebo: Placebo was administered with the same ladarixin schedule.
Number of Participants With an HbA1c Reduction From Baseline of ≥0.50% (Absolute Difference) Without Episodes of Severe Hypoglycemia.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study, up to week 26 (day 182)

Population: randomized patients

Number of Patients With Treatment Emergent Adverse Events (TEAEs) of Any Kind From the Beginning of Study Treatment administration to up to the End of Study Participation was reported. AE= any untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. serious AE (SAE)= any adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. non serious AE(nsAE)= any adverse drug experience associated with the use of the Product in humans, whether or not considered drug-related, which is not a Serious Adverse Event.

Outcome measures

Outcome measures
Measure	Ladarixin n=1 Participants 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. Ladarixin: 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	Placebo n=1 Participants Matching placebo was administered with the same treatment schedule of the IMP. Placebo: Placebo was administered with the same ladarixin schedule.
Number of Patients With Treatment Emergent Adverse Events (TEAEs) of Any Kind From the Beginning of Study Treatment to up to the End of Study Participation	0 Participants	0 Participants

Adverse Events

Ladarixin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Development & Operations

Dompé Farmaceutici SpA

Phone: +30 902 583831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place