PRE1BRAZIL Protocol: A Randomized Controlled Trial to Evaluate the Effectiveness and Safety of the DPP-4 Inhibitor Alogliptin in Delaying the Progression of Stage 2 Type 1 Diabetes

• Published in: Diabetes, metabolic syndrome and obesity Vol. 17; pp. 857 - 864
• Main Authors: Penaforte-Saboia, Jaquellyne Gurgel, Couri, Carlos Eduardo Barra, Albuquerque, Natasha Vasconcelos, Linard, Lana Livia Peixoto, Araújo, Daniel Autran Cavalcante, de Oliveira, Sherida Karanini Paz, Gomes, Thisciane Ferreira Pinto, Pinheiro, Marcelo Maia, Castelo, Maria Helane Costa Gurgel, Fernandes, Virgínia Oliveira, Montenegro Júnior, Renan Magalhães
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01-01-2024; Dove; Dove Medical Press
• Subjects: clinical trial protocol; Clinical trials; Dextrose; Diabetes therapy; dpp-4i; Glucose; Glucose tolerance tests; Inflammation; Medical research; Medicine, Experimental; Pancreatic beta cells; Product development; stage 2 t1dm; Study Protocol; Type 1 diabetes; Type 2 diabetes; Web applications; Brazil; type 1 diabetes; stage 2 T1DM; DPP-4i; web applications; clinical trial protocol
• ISSN: 1178-7007; 1178-7007
• DOI: 10.2147/DMSO.S437635

The incidence of Type 1 Diabetes Mellitus (T1DM) is on the rise. Since there is no curative treatment, it is urgent to look for therapies that can delay disease progression and protect pancreatic β-cells. Dipeptidyl peptidase-4 inhibitors (DPP-4i) have shown potential in modulating inflammation and preventing β-cell destruction. This protocol describes an upcoming trial to evaluate the effectiveness of the DPP-4i alogliptin in delaying the progression of stage 2 (presymptomatic) to stage 3 (symptomatic) T1DM.
We propose a two-year, two-arm, multicenter, randomized, open-label clinical trial targeting Brazilian patients aged 18 to 35 with stage 2 T1DM. The study, facilitated by the custom-developed "PRE1BRAZIL" web application, aims to enroll 130 participants. They will be randomly assigned in a 1:1 ratio to either a treatment group (alogliptin 25 mg daily plus regular clinical and laboratory assessments) or a control group (regular assessments only). The primary outcome is the rate of progression to stage 3 T1DM. Secondary outcomes include changes in A1c levels, glucose levels during a 2-hour oral glucose tolerance test (OGTT), C-peptide levels, exogenous insulin requirements, Insulin-Dose Adjusted A1c (IDAA1c), and the incidence of diabetic ketoacidosis (DKA) in those advancing to stage 3.
This protocol outlines the first randomized clinical trial (RCT) to investigate the impact of a DPP-4i in the presymptomatic stage of T1DM. The trial is designed to provide critical insights into the role of DPP-4i in the secondary prevention of T1DM. Utilizing the "PRE1BRAZIL" web application is expected to enhance participant enrollment and reduce operational costs.
Brazilian Registry of Clinical Trials.