UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039436 |
|---|---|
| Receipt number | 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 | 2022/11/18 09:16:47 |
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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
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
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Inuyama Chuo General Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044959
