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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039436
Receipt No. R000044959
Scientific Title Prediction for glycemic variability in patients treated with IDegLira
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/08

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Basic information
Public title Prediction for glycemic variability in patients treated with IDegLira
Acronym Prediction for glycemic variability in IDegLira
Scientific Title Prediction for glycemic variability in patients treated with IDegLira
Scientific Title:Acronym Prediction for glycemic variability in IDegLira
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 how to predict glycemic variability or hypoglycemia in patients treated with IDegLira from a few measurement
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A time and a cutoff value which can the most exactly predict TIR (70 to 180 mg/dL) more than 70 percent in all 50 patients
Key secondary outcomes Times which the most correlate to CV or TBR(less than 70 mg/dL) in all 50 patients
Times and cutoff values which can the most exactly predict CV less than 36 percent or TBR(less than 70 mg/d)less than 4 percent in all 50 patients
Times during daytime where differences between two glucose levels the most correlate to CV or TBR(less than 70 mg/dL)in all 50 patients
Times during daytime where differences between two glucose levels can the most exactly predict CV less than 36 percent or TBR(less than 70 mg/dL) less than 4 percent in all 50 patients and those cutoff values


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
90 years-old >=
Gender Male and Female
Key inclusion criteria 50 outpatients with type 2 diabetes treated with insulin for 3 month or longer
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Soichi
Middle name
Last name Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code 484-8511
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name Soichi
Middle name
Last name Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code 484-8511
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization Inuyama Chuo General Hospital
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 Inuyama Chuo General Hospital
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
Tel 0568-62-8111
Email souichi19811225@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
2020 Year 02 Month 08 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
2019 Year 10 Month 01 Day
Date of IRB
2020 Year 01 Month 24 Day
Anticipated trial start date
2020 Year 02 Month 10 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Outpatients with type 2 diabetes treated with insulin for 3 month or longer receive IDegLira for more than 1 month (the same dose for 2 weeks just before hospitalization and 24-h glucose levels are monitored during hospitalization using CGM.

Management information
Registered date
2020 Year 02 Month 08 Day
Last modified on
2020 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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