An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes
(2022) In Journal of Clinical Medicine 11(7).- Abstract
We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels,... (More)
We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels, and stimulated C-peptide were observed between the Itolizumab and placebo groups at 52 weeks. A significant decrease in stimulated C-peptide was observed during the follow-up period (p = 0.012). One subject treated with 1.6 mg of Itolizumab showed a marked increase in the levels of stimulated C-peptide three years after completion of the trial. Taken together, this is the first study to demonstrate that combination treatment with Itolizumab and insulin is safe in humans and does not affect the residual function of beta cells up to 52 weeks. The findings from our study show preliminary evidence that high doses of Itolizumab could potentially arrest the loss of beta cell function in the long term. Further studies with a longer follow-up and larger numbers of patients are envisaged to assess the effect with high dose Itolizumab.
(Less)
- author
- organization
- publishing date
- 2022-04-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- C-peptide, Human trials, Insulin, Itolizumab, Type 1 diabetes
- in
- Journal of Clinical Medicine
- volume
- 11
- issue
- 7
- article number
- 1789
- publisher
- MDPI AG
- external identifiers
-
- scopus:85126926126
- pmid:35407396
- ISSN
- 2077-0383
- DOI
- 10.3390/jcm11071789
- language
- English
- LU publication?
- yes
- id
- 47765788-4ff1-47a7-ae1b-65485276be02
- date added to LUP
- 2022-04-19 14:08:30
- date last changed
- 2024-04-06 11:14:43
@article{47765788-4ff1-47a7-ae1b-65485276be02,
abstract = {{<p>We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels, and stimulated C-peptide were observed between the Itolizumab and placebo groups at 52 weeks. A significant decrease in stimulated C-peptide was observed during the follow-up period (p = 0.012). One subject treated with 1.6 mg of Itolizumab showed a marked increase in the levels of stimulated C-peptide three years after completion of the trial. Taken together, this is the first study to demonstrate that combination treatment with Itolizumab and insulin is safe in humans and does not affect the residual function of beta cells up to 52 weeks. The findings from our study show preliminary evidence that high doses of Itolizumab could potentially arrest the loss of beta cell function in the long term. Further studies with a longer follow-up and larger numbers of patients are envisaged to assess the effect with high dose Itolizumab.</p>}},
author = {{Cabrera-Rode, Eduardo and Cubas-Dueñas, Ileana and Rodríguez-Acosta, Janet and García-García, Yudith and Torres-López, Yelena and Prieto-Noa, Claudia and Vázquez-Izada, Bárbara M. and Ruíz-Reinoso, Maité and Echevarría-Valdés, Ragmila and Álvarez-álvarez, Aimee and Domínguez-Alonso, Emma and Conesa-González, Ana Ibis and González-Calero, Teresa and Robles-Torres, Erick and Turcios-Tristá, Silvia Elena and Senra-Estévez, Elizabeth and Hernández-Casaña, Patricia and Sarmiento, Luis}},
issn = {{2077-0383}},
keywords = {{C-peptide; Human trials; Insulin; Itolizumab; Type 1 diabetes}},
language = {{eng}},
month = {{04}},
number = {{7}},
publisher = {{MDPI AG}},
series = {{Journal of Clinical Medicine}},
title = {{An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes}},
url = {{http://dx.doi.org/10.3390/jcm11071789}},
doi = {{10.3390/jcm11071789}},
volume = {{11}},
year = {{2022}},
}