UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060751 |
|---|---|
| Receipt number | R000069517 |
| Scientific Title | Comparative Efficacy, Safety, and Daytime Function of Vornorexant in Insomnia Patients with Type 2 Diabetes: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 10:04:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparative Efficacy and Safety of Vornorexant in Insomnia Patients with Type 2 Diabetes
Acronym
Comparative Efficacy and Safety of Vornorexant in Insomnia Patients with Type 2 Diabetes
Scientific Title
Comparative Efficacy, Safety, and Daytime Function of Vornorexant in Insomnia Patients with Type 2 Diabetes: A Prospective Observational Study
Scientific Title:Acronym
Comparative Efficacy, Safety, and Daytime Function of Vornorexant in Insomnia Patients with Type 2 Diabetes: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athens Insomnia Scale (Comparison between pre-treatment and 8 weeks after administration)
Key secondary outcomes
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))
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuya |
| Middle name | |
| Last name | Hamanoue |
Organization
Hamanoue Internal Medicine
Division name
Internal Medicine
Zip code
810-0044
Address
2-3-21, ropponmatsu chuo-ku, Fukuoka
TEL
092-738-1350
n@hamanoue.com
Public contact
Name of contact person
| 1st name | Nobuya |
| Middle name | |
| Last name | Hamanoue |
Organization
Hamanoue Internal Medicine
Division name
Internal Medicine
Zip code
810-0044
Address
2-3-21, ropponmatsu chuo-ku, Fukuoka
TEL
092-738-1350
Homepage URL
n@hamanoue.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SOUKEN Co., Ltd. Shiba Palace Clinic Ethics Review Committee
Address
Daiwa A Hamamatsucho, 6F 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1555
jimukyoku@mail.souken-r.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study examining the association between insomnia and glycemic control in patients with concomitant type 2 diabetes.
The primary observation factor was insomnia severity (Athens Insomnia Scale score), with secondary endpoints including changes in values such as HbA1c.
The sampling method employed consecutive cases from outpatient visits at a single facility.
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069517
