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TerminatedNCT04628481Updated Aug 31, 2026Results posted

A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

A Phase 2 interventional study of Ladarixin and Placebo in Recent Onset type1 Diabetes, sponsored by Dompé Farmaceutici S.p.A. Terminated at 57 sites in 8 countries. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Dompé Farmaceutici S.p.A · Phase 2, Interventional, and Treatment

Why this study was terminated
The study was stopped due to futility as per protocol
Phase
Phase 2
Study type
Interventional
Enrollment
289
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
All
01

Study summary

Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients.

The safety of ladarixin in the specific clinical setting will be also evaluated.

Read the detailed description

The study will be a phase 2, multicenter, double-blind, placebo-controlled study. It will randomize approximately 130-140 patients (with up to an estimated 15-20% adolescents), with recent onset (within 180 days from 1st insulin administration) type 1 diabetes (T1D), assigned (2:1) to receive either oral ladarixin treatment (400 mg b.i.d. for 13 cycles of 14 days on/14 days off - treatment group) or placebo (control group). Recruitment will be competitive among the study sites, until the planned number of patients is randomized.

Ladarixin and placebo will be both administered for 1 year. All patients will be followed-up for 24 months from the 1st administration of the study medication. After the initial 12-m treatment period, all patients will enter into a 12-month follow-up (total period 24-month after first IMP administration). The study database (DB) will be locked when the last randomized patient has completed the month 12 visit (or being lost in follow-up), and relative data have been fully reconciled and cleaned; at that point, the DB will be unblinded and all endpoints, including the 6-month primary endpoint, will be analyzed, and the follow-up will continue under open-label conditions up to month 24.

02

Conditions studied

  • Recent Onset type1 Diabetes

Keywords

  • type1 diabetes
03

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female patients aged 14-45 years, inclusive;
  2. Recent onset T1D (1st IMP dose within 180 days from 1st insulin administration);
  3. 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);
  4. Require, or has required at some time, insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII).
  5. Fasting C peptide \< 0.205nmol/L;
  6. Residual beta-cell function as per peak stimulated (MMTT) C-peptide level >0.2nmol/L; MMTT should not be performed within one week of resolution of a diabetic ketoacidosis event;
  7. Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
  8. Patients who have given written informed consent prior of any study-related procedure not part of standard medical care (participants under the age of 18, shall provide an assent for the study as per country requirements). Specific consent must be given by adolescents to be selected for the full PK analysis.

Exclusion criteria

Exclusion Criteria:

  1. A type 2 diabetes diagnosis or any other unstable chronic disease for which dose adjustment of specific medication is anticipated during the trial;
  2. Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation;
  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];
  4. Hypoalbuminemia defined as serum albumin \< 3 g/dL;
  5. QTcF > 470 msec;
  6. Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;
  7. A history of significant cardiovascular disease/abnormality;
  8. Known hypersensitivity to non-steroidal anti-inflammatory drugs;
  9. Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index [i.e. phenytoin, warfarin, sulphonylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose amitriptyline (> 50 mg/day)];
  10. Previous (past 2 weeks) 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.);
  11. Past (past month) or current administration of any immunosuppressive medications (including oral or systemic corticosteroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system;
  12. Significant systemic infection during the 4 weeks before the 1st 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);
  13. History of positive status for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV..
  14. 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); abstinence.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
289 participants (actual)

Study arms

  • Experimental
    Ladarixin

    400 mg b.i.d. for 13 cycles of 14 days on/14 days off

    Drug: Ladarixin

  • Placebo comparator
    Placebo

    matching placebo b.i.d. for 13 cycles of 14 days on/14 days off

    Drug: Placebo

Interventions

  • DrugLadarixin

    Oral ladarixin twice a day for 13 cycles

    Also known as: allosteric inhibitor of CXCL8 (IL-8), CXCR1 and CXCR2 receptors

  • DrugPlacebo

    Oral placebo twice a day for 13 cycles

05

What researchers measure

Primary outcomes

  1. Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT)

    Change from baseline in the 2-hour C-peptide Area Under the Curve (AUC) following a Mixed-Meal Tolerance Test (MMTT) at Month 6. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Month 6 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the Month 6 measurement. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.

    Time frame: Baseline and at Month 6

Secondary outcomes

  1. Change From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 12, 18, and 24

    Change from baseline in the 2-hour C-peptide AUC following a MMTT at Months 6, 12, and 18. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Months 12, 18 and 24 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the measurement at the timepoint of interest. Intermediate timepoints were included as covariates in the model. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value.

    Time frame: Baseline and at Months 12, 18, and 24

  2. Change in Glycated Hemoglobin (HbA1c) From Baseline

    The change from baseline in HbA1c was analyzed using an adjusted ANCOVA model. The dependent variable is the change from baseline in HbA1c at each respective time point, with treatment, age group, sex, and BMI group as qualitative independent variables and the baseline value as a quantitative covariate. . Missing data are addressed via Multiple Imputation (MI) using a retrieved dropout approach, where values are imputed based on a regression model incorporating treatment arm, baseline value, and intermediate assessments as covariates. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.

    Time frame: Baseline and at Months 6, 12, 18 and 24

  3. Percentage of Participants With HbA1c <7% Who Did Not Experience Severe Hypoglycemic Events During Treatment

    The proportion of participants with HbA1c \< 7% was calculated by timepoint: the numerator was the number of participants with events occurring at a specific timepoint (month X visit), without cumulating participants with events up to that timepoint. Participants with severe hypoglycemic events were considered cumulatively and only events up to month 12 were considered (condition was evaluated by considering treatment period only). If HbA1c ≥ 7% or the participant had experienced a severe hypoglycemic event, then the endpoint was equal to "No" even in the case of one missing component. If either the HbA1c or severe hypoglycemic event data was missing, but the other satisfied the criteria for the endpoint, then the response to the endpoint was missing.

    Time frame: At Months 6, 12, 18, and 24

  4. Average (Previous 3 Days) Daily Insulin Requirement International Units Per Kilogram Per Day (IU/kg/Day)

    The average daily insulin requirement at each visit was calculated from the daily insulin requirement measured at the 3 days prior to the visit.

    Time frame: At Months 6, 12, 18, and 24

  5. Percentage of Participants With HbA1c <7% and Daily Insulin Requirement <0.5 IU/kg/Day

    Percentage of participants with HbA1c \<7% and daily insulin requirement \<0.5 (IU/Kg/day) was calculated for each time point, the numerator is the number of participants in each treatment group with events occurring at a specific timepoint, and the denominator is the number of participants in each treatment group reaching the specific visit.

    Time frame: At Months 6, 12, 18, and 24

  6. Number of Self-reported Episodes of Severe Hypoglycemia

    This outcome assessed the total number of self-reported episodes of severe hypoglycemia occurring across all participants.

    Time frame: Post-baseline up to Month 24

  7. Percentage of Patients Not Requiring Insulin Therapy

    This outcome assessed the percentage of participants who did not require an insulin therapy at the timepoint of interest.

    Time frame: Months 6, 12, 18 and 24

  8. Estimated Glucose Disposal Rate (eGDR)

    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. The eGDR was calculated using a formula incorporating Glycated Hemoglobin (HbA1c), hypertension status (blood pressure), and the Waist-to-Hip Ratio (WHR), with results expressed in milligrams per kilogram per minute (mg/kg/min).

    Time frame: Months 6, 12, 18, and 24

06

Results

Posted Aug 31, 2026

Participant flow

A total of 141 participants were randomized in the study and 140 participants received treatment.

Run-in Period (180 Days)
Participant flow — Run-in Period (180 Days)
MilestoneLadarixinPlaceboRun-in
Started00289
Completed00141
Not completed00148
Withdrew: Failure to meet continuation criteria00131
Withdrew: Lost to follow-up001
Withdrew: Physician decision001
Withdrew: Protocol-specific withdrawal criterion met001
Withdrew: Withdrawal by subject0014
Treatment Period (12 Months)
Participant flow — Treatment Period (12 Months)
MilestoneLadarixinPlaceboRun-in
Started95460
Completed65260
Not completed30200
Withdrew: Discontinuation criteria met200
Withdrew: Lost to follow-up320
Withdrew: Withdrawal by subject14120
Withdrew: Physician decision110
Withdrew: Pregnancy200
Withdrew: Unavailable due to travel (abroad)130
Withdrew: Study terminated by sponsor720

Outcome measures

PrimaryChange From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT)

Change from baseline in the 2-hour C-peptide Area Under the Curve (AUC) following a Mixed-Meal Tolerance Test (MMTT) at Month 6. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Month 6 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the Month 6 measurement. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.

Time frame:
Baseline and at Month 6
Reported as:
Mean · nanomole*hour/Liter (nmol*hr/L)
Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT)
nanomole*hour/Liter (nmol*hr/L)LadarixinPlacebo
Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT)-0.284 (-0.453 to -0.114)-0.151 (-0.373 to 0.071)
Statistical analysis
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.19582 · Adjusted mean difference: -0.133 · 95% CI -0.334 to 0.068Rubin's rule was used to combine results from multiple imputed datasets.
SecondaryChange From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 12, 18, and 24

Change from baseline in the 2-hour C-peptide AUC following a MMTT at Months 6, 12, and 18. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Months 12, 18 and 24 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the measurement at the timepoint of interest. Intermediate timepoints were included as covariates in the model. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value.

Time frame:
Baseline and at Months 12, 18, and 24
Reported as:
Mean · nmol*hr/L
Change From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 12, 18, and 24
nmol*hr/LLadarixinPlacebo
Month 12-0.426 (-0.767 to -0.084)-0.447 (-0.948 to 0.054)
Month 18-0.574 (-0.991 to -0.157)-0.524 (-1.163 to 0.114)
Month 24-0.661 (-8.201 to 6.880)-0.843 (-14.345 to 12.660)
Statistical analysis
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.92077 · Adjusted mean difference: 0.021 · 95% CI -0.398 to 0.440Rubin's rule was used to combine results from multiple imputed datasets.
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.87123 · Adjusted mean difference: -0.050 · 95% CI -0.652 to 0.552Rubin's rule was used to combine results from multiple imputed datasets.
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.96748 · Adjusted mean difference: 0.182 · 95% CI -8.570 to 8.934Rubin's rule was used to combine results from multiple imputed datasets.
SecondaryChange in Glycated Hemoglobin (HbA1c) From Baseline

The change from baseline in HbA1c was analyzed using an adjusted ANCOVA model. The dependent variable is the change from baseline in HbA1c at each respective time point, with treatment, age group, sex, and BMI group as qualitative independent variables and the baseline value as a quantitative covariate. . Missing data are addressed via Multiple Imputation (MI) using a retrieved dropout approach, where values are imputed based on a regression model incorporating treatment arm, baseline value, and intermediate assessments as covariates. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.

Time frame:
Baseline and at Months 6, 12, 18 and 24
Reported as:
Mean · percentage of glycosylated hemoglobin
Change in Glycated Hemoglobin (HbA1c) From Baseline
percentage of glycosylated hemoglobinLadarixinPlacebo
Month 60.500 (-0.668 to 1.667)0.032 (-1.881 to 1.944)
Month 12-0.267 (-0.681 to 0.148)-0.280 (-0.779 to 0.219)
Month 18-0.031 (-0.713 to 0.652)-0.180 (-1.074 to 0.714)
Month 24-0.007 (-1.383 to 1.369)0.080 (-1.823 to 1.982)
Statistical analysis
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.52800 · Adjusted mean difference: 0.468 · 95% CI -0.985 to 1.921Rubin's rule was used to combine results from multiple imputed datasets.
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.95542 · Adjusted mean difference: 0.013 · 95% CI -0.450 to 0.476Rubin's rule was used to combine results from multiple imputed datasets.
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.78527 · Adjusted mean difference: 0.149 · 95% CI -0.926 to 1.225Rubin's rule was used to combine results from multiple imputed datasets.
  • Ladarixin vs Placebo · Adjusted ANCOVA · p = 0.93685 · Adjusted mean difference: -0.087 · 95% CI -2.233 to 2.059Rubin's rule was used to combine results from multiple imputed datasets.
SecondaryPercentage of Participants With HbA1c <7% Who Did Not Experience Severe Hypoglycemic Events During Treatment

The proportion of participants with HbA1c \< 7% was calculated by timepoint: the numerator was the number of participants with events occurring at a specific timepoint (month X visit), without cumulating participants with events up to that timepoint. Participants with severe hypoglycemic events were considered cumulatively and only events up to month 12 were considered (condition was evaluated by considering treatment period only). If HbA1c ≥ 7% or the participant had experienced a severe hypoglycemic event, then the endpoint was equal to "No" even in the case of one missing component. If either the HbA1c or severe hypoglycemic event data was missing, but the other satisfied the criteria for the endpoint, then the response to the endpoint was missing.

Time frame:
At Months 6, 12, 18, and 24
Reported as:
Number · percentage of participants
Percentage of Participants With HbA1c <7% Who Did Not Experience Severe Hypoglycemic Events During Treatment
percentage of participantsLadarixinPlacebo
Month 644.355.6
Month 1246.239.4
Month 1844.148.3
Month 2441.040.9
SecondaryAverage (Previous 3 Days) Daily Insulin Requirement International Units Per Kilogram Per Day (IU/kg/Day)

The average daily insulin requirement at each visit was calculated from the daily insulin requirement measured at the 3 days prior to the visit.

Time frame:
At Months 6, 12, 18, and 24
Reported as:
Mean · IU/Kg/Day
Average (Previous 3 Days) Daily Insulin Requirement International Units Per Kilogram Per Day (IU/kg/Day)
IU/Kg/DayLadarixinPlacebo
Month 60.39 ± 0.230.34 ± 0.17
Month 120.41 ± 0.230.39 ± 0.18
Month 180.43 ± 0.220.47 ± 0.27
Month 240.47 ± 0.200.46 ± 0.23
SecondaryPercentage of Participants With HbA1c <7% and Daily Insulin Requirement <0.5 IU/kg/Day

Percentage of participants with HbA1c \<7% and daily insulin requirement \<0.5 (IU/Kg/day) was calculated for each time point, the numerator is the number of participants in each treatment group with events occurring at a specific timepoint, and the denominator is the number of participants in each treatment group reaching the specific visit.

Time frame:
At Months 6, 12, 18, and 24
Reported as:
Number · percentage of participants
Percentage of Participants With HbA1c <7% and Daily Insulin Requirement <0.5 IU/kg/Day
percentage of participantsLadarixinPlacebo
Month 659.361.1
Month 1258.248.5
Month 1857.444.8
Month 2443.837.5
SecondaryNumber of Self-reported Episodes of Severe Hypoglycemia

This outcome assessed the total number of self-reported episodes of severe hypoglycemia occurring across all participants.

Time frame:
Post-baseline up to Month 24
Reported as:
Number · Number of events
Number of Self-reported Episodes of Severe Hypoglycemia
Number of eventsLadarixinPlacebo
Number of Self-reported Episodes of Severe Hypoglycemia27876
SecondaryPercentage of Patients Not Requiring Insulin Therapy

This outcome assessed the percentage of participants who did not require an insulin therapy at the timepoint of interest.

Time frame:
Months 6, 12, 18 and 24
Reported as:
Number · percentage of participants
Percentage of Patients Not Requiring Insulin Therapy
percentage of participantsLadarixinPlacebo
Month 61.20
Month 1202.8
Month 1803.2
Month 2404.0
SecondaryEstimated Glucose Disposal Rate (eGDR)

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. The eGDR was calculated using a formula incorporating Glycated Hemoglobin (HbA1c), hypertension status (blood pressure), and the Waist-to-Hip Ratio (WHR), with results expressed in milligrams per kilogram per minute (mg/kg/min).

Time frame:
Months 6, 12, 18, and 24
Reported as:
Mean · mg/kg/min
Estimated Glucose Disposal Rate (eGDR)
mg/kg/minLadarixinPlacebo
Month 69.56 ± 3.018.26 ± 4.52
Month 129.37 ± 3.147.89 ± 4.77
Month 189.64 ± 2.878.78 ± 2.34
Month 249.29 ± 3.368.72 ± 3.17

Adverse events

Collected over Up to Month 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ladarixin0/94 (0%)1/94 (1.1%)71/94 (75.5%)
Placebo0/46 (0%)1/46 (2.2%)33/46 (71.7%)
Run-in0/289 (0%)0/289 (0%)10/289 (3.5%)
Most frequent serious events
Most frequent serious events
EventLadarixinPlaceboRun-in
GastroenteritisInfections and infestations0/941/460/289
Abortion spontaneousPregnancy, puerperium and perinatal conditions1/940/460/289
Most frequent other events
Showing 10 of 18
Most frequent other events
EventLadarixinPlaceboRun-in
COVID-19Infections and infestations25/949/461/289
NasopharyngitisInfections and infestations17/943/461/289
DyspepsiaGastrointestinal disorders17/941/460/289
PyrexiaGeneral disorders11/942/461/289
HypoglycaemiaMetabolism and nutrition disorders11/943/465/289
Upper respiratory tract infectionInfections and infestations10/943/460/289
Oropharyngeal painRespiratory, thoracic and mediastinal disorders9/940/460/289
CoughRespiratory, thoracic and mediastinal disorders5/944/460/289
InfluenzaInfections and infestations8/942/460/289
HeadacheNervous system disorders8/943/460/289

Baseline characteristics

Full analysis set (FAS), consisting of all participants who were randomized and received at least one dose of investigational product.

Age, Continuous
Age, Continuous(years)LadarixinPlaceboTotal
Mean26.4 ± 8.126.2 ± 8.826.4 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)LadarixinPlaceboTotal
Female37946
Male573794
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LadarixinPlaceboTotal
Black or African American202
White9242134
Other011
Multiple022
American Indian or Alaska Native011
07

Study locations

57 sites
  • University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC)
    Birmingham, Alabama 35294, United States
  • Phoenician Centers for Research and Innovation
    Phoenix, Arizona 85021, United States
  • University of California San Diego
    La Jolla, California 92093, United States
  • Center of Excellence in Diabetes & Endocrinology (CEDE)
    Sacramento, California 95821-2123, United States
  • University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic
    Aurora, Colorado 80045, United States
  • Christiana Care Endocrinology Specialists
    Newark, Delaware 19713, United States
  • Diabetes Care Center - Hudson
    Hudson, Florida 34667-7151, United States
  • Global Life Research Network
    Miami, Florida 33155, United States
  • AdventHealth (Florida Hospital) - Diabetes Institute - Orlando
    Orlando, Florida 32804, United States
  • Atlanta Diabetes Associates (ADA)
    Atlanta, Georgia 30318, United States
  • The University of Chicago
    Chicago, Illinois 60637, United States
  • Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical
    Springfield, Illinois 62711, United States
  • Indiana University - Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • The Cotton-O'Neil Diabetes and Endocrinology Center
    Topeka, Kansas 66606-28, United States
  • University of Louisville
    Louisville, Kentucky 40292, United States
  • Joslin Diabetes Center, Harvard Medical School
    Boston, Massachusetts 02215, United States
  • UBMD Physicians Group - Pediatrics - Conventus
    Buffalo, New York 14203, United States
  • "WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location"
    Raleigh, North Carolina 27610, United States
  • University of Pennsylvania Perelman School of Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • UPMC Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
  • University of Pittsburgh - UPMC
    Pittsburgh, Pennsylvania 15261, United States
  • Cook Children's Endocrinology and Diabetes Program
    Fort Worth, Texas 76104, United States
  • Texas Children's Hospital
    Houston, Texas 77030, United States
  • Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center
    Norfolk, Virginia 23510, United States
  • Clinique du Sud Luxembourg - Vivialia-Arlon
    Arlon, Belgium
  • Universitair Ziekenhuis Brussel (UZB)
    Jette, Belgium
  • General Hospital AZ Nikolaas
    Sint-Niklaas, Belgium
  • Aleksandre Aladashvili Clinic LLC
    Tbilisi, 48102, Georgia
  • National Center for Diabetes Research LTD
    Tbilisi, 48159, Georgia
  • National Institute of Endocrinology LTD
    Tbilisi, 48159, Georgia
  • Tbilisi Heart and Vascular Clinic LTD
    Tbilisi, 48159, Georgia
  • Medical Center - University of Freiburg
    Freiburg im Breisgau, Germany
  • Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III
    Glessen, 35392, Germany
  • Diabestesinstitut Heidelberg
    Heidelberg, Germany
  • Die Praxis am Ludwigsplatz
    Ludwigshafen am Rhein, Germany
  • Institut fuer Diabetes forschung in Muenster (IDFM)
    Münster, Germany
  • Schwerpunktpraxis fuer Diabetes & Ernaehrungsmedizin
    Münster, Germany
  • Soroka Medical Center
    Beersheba, Israel
  • Schneider Children's Medical Center, Petah Tikva
    Petah Tikva, 4920235, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
  • Ospedale Pediatrico G. Salesi - Centro Regionale di Diabetologia Clinica Pediatrica
    Ancona, 60123, Italy
  • Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari
    Bari, 70124, Italy
  • Università degli Studi Magna Graecia di Catanzaro, Azienda Ospedaliero-Universitaria Mater Domini
    Catanzaro, Italy
  • Universitá degli Studi di Milano - Ospedale Luigi Saco
    Milan, 20157, Italy
  • Centro regionale di Diabetologia Pediatrica "G. Stoppoloni", Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
    Naples, Italy
  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
    Palermo, 90127, Italy
  • Università Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
    Roma, 00128, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu
    Roma, Italy
  • Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"
    Roma, Italy
  • "Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I
    Rome, 00161, Italy
  • Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
    Belgrade, 11000, Serbia
  • University Children's Hospital
    Belgrade, Serbia
  • Clinical center Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases
    Kragujevac, 34000, Serbia
  • Clinical Center Nis, Clinic for endocrinology
    Niš, 18000, Serbia
  • Clinical Center Nis, Clinic for endocrinology
    Niš, Serbia
  • University Children's Hospital, University Medical Center Ljubljana
    Ljubljana, Slovenia
08

References and documents

Study documents

  • Study protocol · Oct 12, 2023
  • Statistical analysis plan · Jul 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04628481
Lead sponsor
Dompé Farmaceutici S.p.A
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Jan 12, 2021
Primary completion
Mar 31, 2025
Completion
Oct 21, 2025
Results posted
Aug 31, 2026
Last update
Aug 31, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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