Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055791) titled 'A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide' on April 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - University of Miyazaki

Condition: Condition - type 2 diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study was to elucidate the appropriate day of the week for administering tilzepatide, a drug used to treat diabetes mellitus. The day of the week with the highest calorie intake will be estimated based on the weekly dietary records of the subject patients, and two dosing days will be set up: Dosing Day A, which is the day after that day, and Dosing Day B, which is the day before that day, and each parameter will be compared after crossing over.

Translated with DeepL.com (free version) Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The day of the week with the highest average caloric intake on each day of the week is used as the reference day, with the next day set as Dose Day A and the day before as Dose Day B. On Dose Day A, tilzepatide 2.5 mg is administered for 4 weeks, on Dose Day B, tilzepatide 5 mg for 4 weeks, and on Dose Day A, tilzepatide 5 mg for 4 weeks. Interventions/Control_2 - The day of the week with the highest average caloric intake on each day of the week is used as the reference day, with the next day set as Dose Day A and the day before as Dose Day B. On Dose Day B, tilzepatide 2.5 mg is administered for 4 weeks, on Dose Day A, tilzepatide 5 mg for 4 weeks, and on Dose Day B, tilzepatide 5 mg for 4 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Patients with type 2 diabetes aged 20-75 years at the time of consent (2) Patients with a body mass index (BMI) of 22 kg/m2 or higher at the time of consent (3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding. Key exclusion criteria - (1) Patients who have difficulty in recording their diet (2) Other subjects deemed inappropriate as research subjects by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 10 Month 09 Day Anticipated trial start date - 2024 Year 12 Month 01 Day Last follow-up date - 2026 Year 05 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063759

Disclaimer: Curated by HT Syndication.