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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04589325
Other study ID # IDIT001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 9, 2022
Est. completion date December 2027

Study information

Verified date November 2023
Source Göteborg University
Contact Marcus Lind, MD, PhD
Phone +46(0)766-183142
Email marcus.lind@gu.se
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


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Study Design


Intervention

Drug:
Ixekizumab
Ixekizumab will be available at a concentration of 80 mg solution for injection in pre-filled syringes. Ixekizumab will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.
Placebo
Placebo will be available at a concentration of 80 mg solution for injection in pre-filled syringes. Placebo will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.

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Sponsors (3)

Lead Sponsor Collaborator
Göteborg University Gothia Forum - Center for Clinical Trial, Statistiska Konsultgruppen

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Time in hypoglycaemia (<3.0 mmol/L) Change in time in hypoglycaemia (<3.0 mmol/L) measured by CGM/FGM from baseline to week 52. 12 months
Other Proinsulin/c-peptide ratio in serum as a measure of beta cell stress Change in proinsulin/c-peptide ratio in serum as a measure of beta cell stress from baseline to week 52. 12 months
Other Time in target (3.9-8 mmol/L) Change in time in target (3.9-8 mmol/L) measured by CGM/FGM from baseline to week 52. 12 months
Other Time in hyperglycaemia >10 mmol/L and = 14 mmol/L Change in time in hyperglycaemia >10 mmol/L and = 14 mmol/L measured by CGM/FGM from baseline to week 52. 12 months
Other Glycaemic variability (mean amplitude of glycemic excursions (MAGE)) Change in glycaemic variability measured by mean amplitude of glycemic excursions (MAGE) by CGM/FGM from baseline to week 52. 12 months
Other Glycaemic variability (coefficient of variation (CV)) Change in glycaemic variability measured by coefficient of variation (CV) by CGM/FGM from baseline to week 52. 12 months
Other Glycaemic variability (standard deviation (SD)) Change in glycaemic variability measured by standard deviation (SD) by CGM/FGM from baseline to week 52. 12 months
Other Proportion of patients with peak residual insulin secretion Change in proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide >0.4 pmol/mL from baseline to week 52 12 months
Other Change in World Health Organization-5 (WHO-5) scores from baseline and week 52. Score 0 to 100; higher value indicates better well-being 12 months
Other Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores from baseline and week 52. Score 0 to 36; higher value indicates better satisfaction and change in satisfaction (score -18 to 18; higher value indicates better change in satisfaction). 12 months
Other Change in Hypoglycaemia Fear Survey (Swe-HFS) scores from baseline and week 52. Score 0 to 4; higher value indicates greater fear. 12 months
Other Change in Problem Areas in Diabetes Scale (PAID) scores from baseline and week 52. Score 0 to 100; higher value indicates greater problems. 12 months
Other Change in International Physical Activity Questionnaire (IPAQ) scores from baseline and week 52. Total Physical Activity Scores are calculated by Metabolic Energy Turnover (MET)-minutes/week score. 12 months
Primary Residual insulin secretion 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. 12 months
Secondary Mean Insulin dosage per kilo bodyweight for 24 hours Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52. 12 months
Secondary Time with glucose levels in range (3.9-10 mmol/L) Change in time with glucose levels in range (3.9-10 mmol/l) measured by CGM/FGM from baseline to week 52. 12 months
Secondary Time in hypoglycaemia (<3.9 mmol/L) Change in time in hypoglycaemia (<3.9 mmol/L) measured by CGM/FGM from baseline to week 52. 12 months
Secondary HbA1c Difference in HbA1c from baseline to week 52. 12 months
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