UMIN-CTR Clinical Trial

Basic information
Public title	Patient Experiences and Perceptions of Living with Refractory Diabetes Mellitus with Insulin Resistance in Japan -A Qualitative Research
Acronym	Refractory Diabetes Mellitus with Insulin Resistance -Patient Experiences and Perceptions in Japan
Scientific Title	Patient Experiences and Perceptions of Living with Refractory Diabetes Mellitus with Insulin Resistance in Japan -A Qualitative Research
Scientific Title:Acronym	Refractory Diabetes Mellitus with Insulin Resistance -Patient Experiences and Perceptions in Japan
Region	Japan

Condition
Condition	Insulin resistance, lipoatrophic diabetes mellitus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Describe experiences and perceptions of patients living with insulin resistance or lipoatrophic diabetes mellitus and understand their needs and priorities of treatment and daily life.
Basic objectives2	Others
Basic objectives -Others	Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Information on experiences and perceptions of patients living with insulin resistance or lipoatrophic diabetes mellitus
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Patients living with insulin resistance or lipoatrophic diabetes mellitus -20+ years of age
Key exclusion criteria	-Not eligible at physician's discretion -Patients currently participating in clinical trials on the efficacy and safety of empagliflozin for refractory diabetes mellitus with insulin resistance (conducted by Kobe University with funding and investigational drug provided by Nippon Boehringer Ingelheim [BI] [jRCT2051190029, jRCT2051190094])
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Nobutaka Middle name Last name Yagi
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Email	nobutaka.yagi@boehringer-ingelheim.com

Public contact
Name of contact person	1st name Nobutaka Middle name Last name Yagi
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Homepage URL
Email	nobutaka.yagi@boehringer-ingelheim.com

Sponsor
Institute	Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Kyoso-kai AMC Nishi-Ume da Clinic Ethics Review Committee
Address	Maruit Nishi-Umeda Building 3F, 3-3-45 Umed a, Kita-ku, Osaka-shi, Osaka, Japan
Tel	06-4797-5660
Email	morikawa@amc-clinic.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	2021 Year 03 Month 22 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	4
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 03 Month 09 Day
Date of IRB	2021 Year 03 Month 18 Day
Anticipated trial start date	2021 Year 03 Month 23 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non-interventional, cohort study

Management information
Registered date	2021 Year 03 Month 22 Day
Last modified on	2021 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049805