Ixekizumab Diabetes Intervention Trial (I-DIT)
- Registration Number
- NCT04589325
- Lead Sponsor
- Göteborg University
- Brief 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.
- Detailed 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 17 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Ixekizumab Ixekizumab -
- Primary Outcome Measures
Name Time Method Residual insulin secretion 12 months Change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) between baseline and week 52.
- Secondary Outcome Measures
Name Time Method Time with glucose levels in range (3.9-10 mmol/L) 12 months Change in time with glucose levels in range (3.9-10 mmol/l) measured by CGM/FGM from baseline to week 52.
Mean Insulin dosage per kilo bodyweight for 24 hours 12 months Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52.
HbA1c 12 months Difference in HbA1c from baseline to week 52.
Time in hypoglycaemia (<3.9 mmol/L) 12 months Change in time in hypoglycaemia (\<3.9 mmol/L) measured by CGM/FGM from baseline to week 52.
Trial Locations
- Locations (17)
Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Skaraborgs sjukhus
🇸🇪Skövde, Sweden
Varbergs sjukhus
🇸🇪Varberg, Sweden
Södra Älvsborg Hospital
🇸🇪Borås, Sweden
Falu Lasarett
🇸🇪Falun, Sweden
Sahlgrenska University Hospital, Östra Hospital
🇸🇪Gothenburg, Sweden
Sahlgrenska University Hospital, Sahlgrenska
🇸🇪Göteborg, Sweden
Karlstad lasarett
🇸🇪Karlstad, Sweden
Kristianstad Hospital
🇸🇪Kristianstad, Sweden
Linköping University Hospital
🇸🇪Linköping, Sweden
Lund University Hospital
🇸🇪Lund, Sweden
Vrinnevi Hospital
🇸🇪Norrköping, Sweden
Centrum för Diabetes,
🇸🇪Stockholm, Sweden
Södersjukhuset Hospital
🇸🇪Stockholm, Sweden
NU-Hospital Group
🇸🇪Uddevalla, Sweden
Uppsala Academic Hospital
🇸🇪Uppsala, Sweden
Örebro University Hospital
🇸🇪Örebro, Sweden