New-onset Type 1 DiabetesPhase 2NCT04899271
A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.
A Phase 2 study testing Ladarixin in people with New-onset Type 1 Diabetes, run by Dompé Farmaceutici S.p.A at 16 sites in 6 countries.
Trial summary
The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function. The safety of ladarixin in the specific clinical setting was also evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- New-onset Type 1 Diabetes
- What is being tested?
- Ladarixin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 14 Dec 2020to 11 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 18-45 years, inclusive;
- New-onset T1D (1st IMP dose within 100 days from 1st insulin administration);
- Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);
- Require, or has required at some time, insulin therapy through multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII);
- Fasting C peptide ≥0.205nmol/L on two occasions;
- Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
- Patients who have given written informed consent prior of any study-related procedure not part of standard medical care.
Who cannot join
- Any other chronic disease, including type 2 diabetes, apart from autoimmune hypothyroidism requiring thyroid hormone replacement only; patients with severe (myxedema) disease potentially requiring immunosuppressive therapy will be excluded;
- Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (see Appendix 14.4.3);
- Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L];
- Hypoalbuminemia defined as serum albumin < 3 g/dL;
- QTcF > 470 msec;
- A history of significant cardiovascular disease/abnormality
Show all 14Show fewer
- Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;
- Known hypersensitivity to non-steroidal anti-inflammatory drugs;
- Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index [i.e., phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (>50 mg/day)];
- Previous (within 2 weeks prior to randomization) and concomitant treatment with antidiabetic agents as metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors, SGLT2-inhibitors or amylin, or any medications known to influence glucose tolerance (e.g. beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin, etc.);
- Past (within 1 month prior to randomization) or current administration of any immunosuppressive medications (including oral, inhaled or systemically injected steroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system;
- Significant systemic infection during the 4 weeks before the first dose of the study drug (e.g., infection requiring hospitalization, major surgery, or IV antibiotics to resolve; other infections, e.g., bronchitis, sinusitis, localized cellulitis, candidiasis, or urinary tract infections, must be assessed on a case-by-case basis by the investigator regarding whether they are serious enough to warrant exclusion);
- Hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV positive serologic status Serologic evidence of current infectious liver disease (hepatitis A, B, or C), including anti hepatitis A virus (immunoglobulin M), hepatitis B surface antigen, or anti hepatitis C virus and HIV;
- Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males). Effective contraceptive measures include a hormonal birth control (e.g. oral pills, long term injections, vaginal ring, patch); the intrauterine device (IUD); a double barrier method (e.g. condom or diaphragm plus spermicide foam).
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Italy6 sites
Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari
Bari, 70124
Università degli Studi Magna Graecia di Catanzaro, Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro, 88100
Universitá degli Studi di Milano - Ospedale Luigi Sacco
Milan, 20157
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, 90127
Università Campus Bio-Medico di Roma (UCBM)
Roma, 00128
"Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I
Rome, 00161
Germany3 sites
Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III
Glessen, 35392
St. Josefskrankenhaus Diabestesinstitut Heidelberg
Heidelberg, 69115
Institut fuer Diabetes forschung in Muenster (IDFM)
Münster, 48145
United States2 sites
Atlanta Diabetes Associates (ADA)
Atlanta, Georgia, 30318
University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic
Aurora, Colorado, 80045
Georgia2 sites
National Center for Diabetes Research LTD
Tbilisi, 48159
National Institute of Endocrinology LTD
Tbilisi, 48159
Serbia2 sites
University of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, 11000
University of Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases
Kragujevac, 34000
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 400 mg Twice a Day Oral Ladarixin in Patients With New-onset Type 1 Diabetes and Preserved Beta-cell Function at Baseline.
The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function.
The safety of ladarixin in the specific clinical setting was also evaluated.
Read the detailed description
This was a phase II clinical trial designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate whether ladarixin is effective in preserving β-cell function and slowing-down the progression of T1D in adult patients with new-onset T1D and preserved β- cell function (fasting C-peptide ≥0.205 nmol/L) at baseline.
Seventy-five (75) patients were to be randomized based on an unbalanced randomization allocation ratio (2:1) to ladarixin hard gelatine capsules for oral administration (2 x 200 mg two times a day [b.i.d.] for 13 cycles of 14 days on/14 days off) or matched placebo. Assuming a 10% drop-out rate, approximately 84 patients were expected to be enrolled and to be treated for 1 year.
Each patient was to be involved in the study for a run-in period (screening and baseline assessments) followed by a randomization visit, a treatment period of 12 months, and a post-randomization period up to 18 months from the 1st treatment dose.
The study enrolment was stopped, though, on 28 March 2022, due to low enrolment rate, at the randomization of the 25th patient. The study terminated early, on 11 October 2023 (LPLV).
Due to the early termination of the study, efficacy analyses were reduced in scope given the limited sample size of the study compared with the one expected.
- Conditions
- New-onset Type 1 Diabetes
- Being tested
- Ladarixin, Placebo
- Keywords
- Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LadarixinDrug
Also called LDX
400 mg b.i.d. for 13 cycles of 14 days on/14 days off
PlaceboOther
Placebo was administered orally with the same scheme of administration of LDX to preserve blinding
| Study group | Role | What they receive |
|---|---|---|
| Ladarixin | Experimental | The treatment group received 400 mg b.i.d. for 13 cycles of 14 days on/14 days off) Receives: Drug: Ladarixin |
| Placebo | Placebo comparator | The control group received matched placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With HbA1c <7% and Daily Insulin Requirement <0.50 IU/Kg/Day at Month 12
The sample size of the study is calculated on the "proportion of patients with a HbA1c < 7% and daily insulin requirement <0.50 IU/Kg/day", a post-hoc composite endpoint derived from data of the phase 2 trial (MEX0114), considering a larger effect size expected from the longer treatment length (one year versus 3 months).
The time frame for the primary endpoint has been set at Month 12 (Week 52) in order to evaluate the potential of ladarixin effects on a long-term projection.
Please note that "proportion" is expressed as "count" (number + % of participants)
Measured: Month 12 (52±2 weeks)
Secondary outcomes (10)
Number of Patients With HbA1c < 7% and Daily Insulin Requirement <0.50 IU/Kg/Day at Months 6 and 18
The sample size of the study is calculated on the "proportion of patients with a HbA1c < 7% and daily insulin requirement <0.50 IU/Kg/day", a post-hoc composite endpoint derived from data of the phase 2 trial (MEX0114), considering a larger effect size expected from the longer treatment length (one year versus 3 months). Follow-up is extended up to 18 months to evaluate the potential persistency of any glycemic benefit. Please note that "proportion" is expressed as "count" (number + % of participants)
Measured: Month 6 (26±2 weeks) and Month 18 (78±2 weeks)
Number of Patients With a Reduction in HbA1c% > 0.5% From Baseline and Daily Insulin Requirement <0.50 IU/Kg/Day at Months 6, 12 and 18
The number of patients with a reduction in HbA1c% > 0.5% from baseline and daily insulin requirement <0.50 IU/Kg/day was calculated at the hereunder specified timepoints.
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks )
Change From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 6, 12 and 18
C-peptide level is a widely used measure of pancreatic beta-cell function and the MMTT is one of the methods for its estimation. AUC stands for Area Under the Curve.
AUC calculation was based on actual rather scheduled timings and it was calculated using the trapezoidal rule. C-peptide 0-120 min AUC (nmol/L) values were calculated based on all Basal-120min C-peptide values. Unscheduled assessments were excluded from the analysis.
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Changes From Baseline in Percentage Glycated Hemoglobin (HbA1c) Levels at Months 6, 12 and 18
HbA1c measurement can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement.
An HbA1c of 6.5% is recommended as the cut point for diagnosing diabetes. A value of less than 6.5% does not exclude diabetes diagnosed using glucose tests. An A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin.
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Number of Patients With HbA1c < 7% Who Did Not Experience Severe Hypoglycemic Events During Treatment at Months 6,12 and 18
For the purpose of this study, a severe hypoglycaemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Overall Number of Self-reported Episodes of Severe Hypoglycemia
For the purpose of this study, a severe hypoglycaemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration. Data reported refer to the overall number of episodes recorded by all analyzed patients in the two arms/groups (Ladarixin and placebo).
Measured: From baseline to study termination (month 18, week 78)
Blood Glucose Levels for Patients Reporting Severe Hypoglycemia at Months 6, 12 and 18
A severe hypoglycemic event was defined as an event with 1 of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.e. glucose, or glucagon administration. Summary statistics of blood glucose level (mg/dL) are provided by treatment group at each time point for patients reporting severe hypoglycemia.
Measured: Months 6 (week 26±2), 12 (week 52±2) and 18 (week 78±2)
Change From Baseline in Average (Previous 3 Days) Daily Insulin Requirements (IU/kg/Day) at Months 6,12 and 18
For the purpose of this study, daily insulin is averaged over the previous 3 days.Insulin requirement (IU/kg/day averaged over the previous 3 days) was to be recorded to Months 6, 12 and 18.
Patients were admitted to intensive diabetes management, according to current ADA recommendation [2014]. Patients were instructed to self-monitor their glucose values at least 4 times a day and to report (glucose meter/log) outcome to the diabetes management team. Insulin intake was adjusted to target HbA1c levels of less than 7% and self-monitored (fingerstick):
- pre-prandial blood glucose of 70-130 mg/dL
- post-prandial blood glucose < 180 mg/dL
- bed-time blood glucose of 110-150 mg/dL
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Change From Baseline in Estimated Glucose Disposal Rate (eGDR) at Months 6, 12 and 18
Estimated Glucose Disposal Rate (eGDR) is a marker for the Assessment of Insulin Resistance and a validated clinical tool for estimating insulin sensitivity in type 1 diabetes.
Measured: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Number of Patients With at Least One Adverse Events (AEs), Serious or Not Serious
An AE is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.
A serious adverse event is an 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.
Measured: Throughout the study up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start14 Dec 2020
- Primary completion27 Apr 2023
- Study completion11 Oct 2023
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for New-onset Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrico M Minnella, MD, Study director, Dompé Farmaceutici
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899271
- Sponsor's protocol ID
- LDX0419
- Other IDs
- 2020-002966-15
- Status last verified
- May 2025
- First submitted
- 10 May 2021
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 400 mg Twice a Day Oral Ladarixin in Patients With New-onset Type 1 Diabetes and Preserved Beta-cell Function at Baseline.
- ClinicalTrials.gov ID
- NCT04899271
- Acronym / sponsor ID
- LDX0419
- Conditions
- New-onset Type 1 Diabetes
- Keywords
- Type 1 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function.
The safety of ladarixin in the specific clinical setting was also evaluated.
Detailed description
This was a phase II clinical trial designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate whether ladarixin is effective in preserving β-cell function and slowing-down the progression of T1D in adult patients with new-onset T1D and preserved β- cell function (fasting C-peptide ≥0.205 nmol/L) at baseline.
Seventy-five (75) patients were to be randomized based on an unbalanced randomization allocation ratio (2:1) to ladarixin hard gelatine capsules for oral administration (2 x 200 mg two times a day [b.i.d.] for 13 cycles of 14 days on/14 days off) or matched placebo. Assuming a 10% drop-out rate, approximately 84 patients were expected to be enrolled and to be treated for 1 year.
Each patient was to be involved in the study for a run-in period (screening and baseline assessments) followed by a randomization visit, a treatment period of 12 months, and a post-randomization period up to 18 months from the 1st treatment dose.
The study enrolment was stopped, though, on 28 March 2022, due to low enrolment rate, at the randomization of the 25th patient. The study terminated early, on 11 October 2023 (LPLV).
Due to the early termination of the study, efficacy analyses were reduced in scope given the limited sample size of the study compared with the one expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ladarixin | Experimental | Drug: LadarixinThe treatment group received 400 mg b.i.d. for 13 cycles of 14 days on/14 days off) |
| Placebo | Placebo comparator | Other: PlaceboThe control group received matched placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female patients aged 18-45 years, inclusive;
- New-onset T1D (1st IMP dose within 100 days from 1st insulin administration);
- Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);
- Require, or has required at some time, insulin therapy through multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII);
- Fasting C peptide ≥0.205nmol/L on two occasions;
Key exclusion criteria (14 listed)
- Any other chronic disease, including type 2 diabetes, apart from autoimmune hypothyroidism requiring thyroid hormone replacement only; patients with severe (myxedema) disease potentially requiring immunosuppressive therapy will be excluded;
- Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (see Appendix 14.4.3);
- Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L];
- Hypoalbuminemia defined as serum albumin < 3 g/dL;
- QTcF > 470 msec;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LadarixinAlso: LDX400 mg b.i.d. for 13 cycles of 14 days on/14 days off | Drug | Ladarixin |
| PlaceboPlacebo was administered orally with the same scheme of administration of LDX to preserve blinding | Other | Placebo |
Primary outcome
Number of Patients With HbA1c <7% and Daily Insulin Requirement <0.50 IU/Kg/Day at Month 12
Time frame: Month 12 (52±2 weeks)
The sample size of the study is calculated on the "proportion of patients with a HbA1c < 7% and daily insulin requirement <0.50 IU/Kg/day", a post-hoc composite endpoint derived from data of the phase 2 trial (MEX0114), considering a larger effect size expected from the longer treatment length (one year versus 3 months). The time frame for the primary endpoint has been set at Month 12 (Week 52) in order to evaluate the potential of ladarixin effects on a long-term projection. Please note that "proportion" is expressed as "count" (number + % of participants)
10 secondary outcomes
Number of Patients With HbA1c < 7% and Daily Insulin Requirement <0.50 IU/Kg/Day at Months 6 and 18
Time frame: Month 6 (26±2 weeks) and Month 18 (78±2 weeks)
Number of Patients With a Reduction in HbA1c% > 0.5% From Baseline and Daily Insulin Requirement <0.50 IU/Kg/Day at Months 6, 12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks )
Change From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 6, 12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Changes From Baseline in Percentage Glycated Hemoglobin (HbA1c) Levels at Months 6, 12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Number of Patients With HbA1c < 7% Who Did Not Experience Severe Hypoglycemic Events During Treatment at Months 6,12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Overall Number of Self-reported Episodes of Severe Hypoglycemia
Time frame: From baseline to study termination (month 18, week 78)
Blood Glucose Levels for Patients Reporting Severe Hypoglycemia at Months 6, 12 and 18
Time frame: Months 6 (week 26±2), 12 (week 52±2) and 18 (week 78±2)
Change From Baseline in Average (Previous 3 Days) Daily Insulin Requirements (IU/kg/Day) at Months 6,12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Change From Baseline in Estimated Glucose Disposal Rate (eGDR) at Months 6, 12 and 18
Time frame: Months 6 (26±2 weeks), 12 (52±2 weeks) and 18 (78±2 weeks)
Number of Patients With at Least One Adverse Events (AEs), Serious or Not Serious
Time frame: Throughout the study up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico M Minnella, MD study director
Dompé Farmaceutici
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ladarixin in people with New-onset Type 1 Diabetes, run by Dompé Farmaceutici S.p.A at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy, Germany, United States, Georgia, Serbia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With HbA1c <7% and Daily Insulin Requirement <0.50 IU/Kg/Day at Month 12 (time frame: Month 12 (52±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.