Comparative Efficacy and Safety of Vornorexant in Insomnia Patients with Type 2 Diabetes

Comparative Efficacy, Safety, and Daytime Function of Vornorexant in Insomnia Patients with Type 2 Diabetes: A Prospective Observational Study - Comparative Efficacy, Safety, and Daytime Function of Vornorexant in Insomnia Patients with Type 2 Diabetes: A Prospective Observational Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060751

Enrollment

Registered

2026-02-26

Start date

2026-02-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Athens Insomnia Scale (Comparison between pre-treatment and 8 weeks after administration)	—

Secondary

Measure	Time frame
Sleep Questionnaire (Comparison between pretreatment and 8 weeks posttreatment) Karolinska Sleepiness Scale (Comparison between pretreatment and 8 weeks posttreatment) Athens Insomnia Scale Achievement Rate (Comparison between pretreatment and 8 weeks posttreatment) Incidence of Adverse Events (Comparison between pretreatment and 8 weeks posttreatment) Routine clinical laboratory tests (HbA1c, LDLC, HDLC, TG, eGFR, BUN, UA, platelets, ALT, AST, gGTP, fibrosis score (FIB4 index, APRI), steatosis score (HSI), BMI, SBP, DBP, pulse wave velocity (PWV), intimamedia thickness (IMT))	—

Measure

Time frame

Sleep Questionnaire (Comparison between pretreatment and 8 weeks posttreatment) Karolinska Sleepiness Scale (Comparison between pretreatment and 8 weeks posttreatment) Athens Insomnia Scale Achievement Rate (Comparison between pretreatment and 8 weeks posttreatment) Incidence of Adverse Events (Comparison between pretreatment and 8 weeks posttreatment) Routine clinical laboratory tests (HbA1c, LDLC, HDLC, TG, eGFR, BUN, UA, platelets, ALT, AST, gGTP, fibrosis score (FIB4 index, APRI), steatosis score (HSI), BMI, SBP, DBP, pulse wave velocity (PWV), intimamedia thickness (IMT))

—

Countries

Japan

Contacts

Public ContactNobuya Hamanoue

Hamanoue Internal Medicine Internal Medicine

n@hamanoue.com092-738-1350

Outcome results