Dompé Farmaceutici S.p.A
Primary objective: To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives: To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. Exploratory objectives (if site is able and deems appropriate to accommodate and conduct these objectives): To determine the effects on insulin sensitivity and circulating markers of inflammation (leukocytes and inflammatory cytokines). Glycemic variability by additional CGM parameters. eGDR and BMI assessments.
Type 1 Diabetes
Ladarixin
Placebo
Phase 2
This study will be a randomized, placebo-controlled, double-blinded, 2- parallel arm, phase II trial. It will enroll up to 86 patients across all genders, 21-65 years, inclusive, with established insulin-requiring T1D and IR, assigned (1:1) to receive either oral ladarixin 400 mg b.i.d. for 7 cycles (26 weeks) of 14 days on/14 days off (treatment group) or matched placebo (control group). Patients will be involved in the trial for 5 study visits, for a total of 28 weeks. Recruitment will be competitive among the study sites, until the planned number of patients is randomized.}}
Study Type : | Interventional |
Estimated Enrollment : | 2 participants |
Masking : | Quadruple |
Masking Description : | Appearance, including packaging and labelling, of the IMP (capsules, packaging) will not allow to recognize actual treatment (either ladarixin or placebo). During the trial, blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further patient care. |
Primary Purpose : | Treatment |
Official Title : | Randomized, Placebo-controlled, Double-blinded, 2-parallel Arm, Clinical Trial Evaluating Ladarixin 400 mg Bid as Adjunctive Therapy to Improve Glycemic Control in Overweight Insulin-resistant Patients With Type 1 Diabetes. |
Actual Study Start Date : | July 27, 2022 |
Estimated Primary Completion Date : | September 18, 2023 |
Estimated Study Completion Date : | September 18, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Ladarixin Ladarixin will be 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. |
Drug: Ladarixin |
Placebo Comparator: Placebo Matching placebo will be administered with the same treatment schedule of the IMP. |
Other: Placebo |
Ages Eligible for Study: | 21 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
F. Spaziani Hospital Frosinone
Frosinone, Italy, 03100
Not yet recruiting
Campus Bio-Medico University of Rome (UCBM) University Polyclinic
Rome, Italy, 00128