Ixekizumab Diabetes Intervention Trial (I-DIT) — I-DIT  

Type1 Diabetes Mellitus Clinical Trial

Official title: The Effect of Anti-IL17 in New-onset Type 1 Diabetes: a Randomized, Double-blind, Placebo-controlled Trial

Status Recruiting

Clinical Trial Summary

Although the clinical onset of type 1 diabetes (T1D) is acute, the progression of T1D occurs over many years often in a patchy manner with inflammation in certain lobes of the pancreas, leaving other lobes unaffected and long-lasting beta cells remain functional decades after diagnosis. Psoriasis share several aspects with T1D, e.g. the patchy inflammatory infiltrate consisting of tissue-resident memory (TRM) T cells, leaky blood vessels that facilitate leukocyte migration and the increased risk for systemic conditions. Moreover, interleukin (IL)-17 has shown to be increased in both persons with psoriasis and T1D. Activation of IL-17/IL-22 pathway is viewed to be both a hallmark of psoriasis and human T1D. Ixekizumab, an anti-IL17 biological agent, has shown marked therapeutic value in the treatment of subjects with psoriasis in several randomized trials and is currently an approved clinical therapy. Due to the many similarities in the current view of pathogenesis and manifestation of T1D and psoriasis it is possible that Ixekizumab can also influence the disease process of T1D.

Clinical Trial Description

In this double-blind, placebo-controlled prospective trial, patients with newly diagnosed T1D will be randomized to receive either Ixekizumab or placebo in addition to their conventional therapy. The primary aim is to examine the effect of Ixekizumab on endogenous insulin production when administered to persons with newly diagnosed T1D. The planned study duration is 52 weeks with an extension phase for 3 years and includes 127 patients at 19 centers in Sweden. During the extension phase the participants will be examined during a visit after 1 and 3 years after the end of the study regarding insulin production (C-peptide and proinsulin secretion during a Mixed Meal Tolerance Test), glycaemic control, T1D auto-antibodies and insulin doses. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

• NCT number: NCT04589325
• Study type: Interventional
• Source: Göteborg University
• Contact: Marcus Lind, MD, PhD
• Phone: +46(0)766-183142
• Email: marcus.lind@gu.se
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2022
• Completion date: December 2027