Tokyo, Feb. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060751) titled 'Comparative Efficacy and Safety of Vornorexant in Insomnia Patients with Type 2 Diabetes' on Feb. 26.
Study Type:
Observational
Primary Sponsor:
Institute - Other
Condition:
Condition - Insomnia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate changes in sleep-related parameters following administration of Vornolexant (Vorzzz) in patients with type 2 diabetes mellitus (T2DM) who experience insomnia, and to assess its efficacy and safety.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with type 2 diabetes, Individuals whose primary complaint is insomnia symptoms (Sleep-onset insomnia, Sleep maintenance insomnia, early morning awakening, etc.), Individuals who understand the instructions and have provided written consent
Key exclusion criteria - Severe hepatic impairment (Child-Pugh Class C), History of hypersensitivity to any component of Vornorexant (Vorzzz), Pregnant or lactating women, Individuals unable to complete questionnaires due to cognitive impairment or other reasons, Other patients deemed unsuitable for the study by the study physician
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 19 Day
Date of IRB - 2026 Year 02 Month 19 Day
Anticipated trial start date - 2026 Year 02 Month 26 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069517
Disclaimer: Curated by HT Syndication.
