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

Type 1 Diabetes Clinical Trial

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.

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05368402
Study type Interventional
Source Dompé Farmaceutici S.p.A
Contact
Status Terminated
Phase Phase 2
Start date July 27, 2022
Completion date September 18, 2023
View Details
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