UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of Clinical Effects of Semaglutide Injection in Outpatients with Type 2 Diabetes
Acronym	Investigation of Clinical Effects of Semaglutide Injection
Scientific Title	Real-World Clinical Effects of Semaglutide Injection in Outpatients with Type 2 Diabetes
Scientific Title:Acronym	Clinical Effects of Semaglutide Injection
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate real-world clinical effects of semaglutide injection in outpatients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of HbA1c at baseline and one, three and six months after semaglutide injection.
Key secondary outcomes	Body weight, Bioelectrical impedance analysis (BIA), Questionnaire of gastrointestinal symptoms, Diabetes treatment satisfaction questionnaire(DTSQ) at baseline and one, three and six months after semaglutide injection. Index of glycemic variability from professional CGM at baseline and six months

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The study term is six months. Participants are outpatients with type 2 diabetes in our hospital. They are categorized as cases of adding semaglutide injection to GLP-1RA-naive or switching from liraglutide and duraglutide use cases to semaglutide injection. Start dose of Semaglutide injection is 0.25mg once a week for the first 4 weeks. After 4 weeks, increase the dose to 0.5mg once a week at week 5. If, after at least 4 weeks on the 0.5 mg dose, additional clinical control is still needed, increase the dose to 1.0 mg once a week. DPP4 inhibitor therapies are discontinued.
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	19 years-old <=
Age-upper limit	91 years-old >
Gender	Male and Female
Key inclusion criteria	Type2 diabetes
Key exclusion criteria	1.Patients with pregnancy 2.Patients with allergy 3.Patients who hospitalize over one week 4.Patients with serious gastrointestinal illness 5.Patients with cancer 6.Patients with a history of diabetic ketoacidosis and hyperglycemic crises 7.Patients with severe infection 8.Patients with high dose corticosteroid
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Nobutoshi Middle name Last name Fushimi
Organization	Ichinomiyanishi Hospital
Division name	Department of Endocrinology and Diabetes
Zip code	494000
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586480077
Email	nobutoshi243@yahoo.co.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Matsubara
Organization	Ichinomiyanishi Hospital
Division name	Research Planning Division
Zip code	494000
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586480077
Homepage URL
Email	matsubara@anzu.or.jp

Sponsor
Institute	Ichinomiynishi Hospital
Institute
Department

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	Ichinomiya Nishi Hospital
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
Tel	0586480077
Email	nobutoshi243@yahoo.co.jp

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	2022 Year 03 Month 01 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	Completed
Date of protocol fixation	2021 Year 08 Month 10 Day
Date of IRB	2021 Year 10 Month 21 Day
Anticipated trial start date	2021 Year 10 Month 21 Day
Last follow-up date	2022 Year 10 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 26 Day
Last modified on	2022 Year 11 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050623