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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029630
Receipt No. R000031895
Scientific Title Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Date of disclosure of the study information 2017/10/19
Last modified on 2019/04/22

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Basic information
Public title Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Acronym Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Scientific Title Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Scientific Title:Acronym Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Region
Japan

Condition
Condition Type 1 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the difference that two different ultra-long acting insulin affect the fasting blood glucose fluctuation in type 1 diabetic patients who are depleted of endogenous insulin secretion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Standard deviation of fasting blood glucose by SMBG
Key secondary outcomes Nocturnal blood glucose fluctuation index by flash glucose monitoring

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention at glargine-U 300
cross over
Interventions/Control_2 Intervention at degludec
cross over
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
99 years-old >
Gender Male and Female
Key inclusion criteria 1) Type 1 diabetes patients who were confirmed to have CPR of less than 0.2 ng / mL at least twice by a conventional measurement method
2) Long-acting or intermediate insulin injection once a day and MDI of super fast-acting or fast-acting insulin have been treated for more than 1 year
3) SMBG can be implemented
4) FGM can be implemented
Key exclusion criteria 1)HbA1c > 9.0%
2)other medication to affect glucose concentarion
3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more)
4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit)
5)severe renal dysfunction (Cr > 2)
6)severe heart failure (NYHA>2)
7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis
8)retinopathy with high bleeding risk
9)pregnant or breast-feeding women
10)Cancer patient
11)psychological disorder
12) others inappropriate for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-76-382-5861
Email kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-76-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 19 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2018 Year 06 Month 08 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031895

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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