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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012198
Receipt No. R000014264
Scientific Title The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Date of disclosure of the study information 2013/11/01
Last modified on 2014/05/27

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Basic information
Public title The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Acronym The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Scientific Title The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
Scientific Title:Acronym The effects of insulin Degludec on glucose fluctuation in patients with type 1 diabetes
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 compare the effects of insulin Decludec on glucose fluctuation with the effects of insulin Glargine by using CGMS(Continuous Glucose Monitoring System)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daily Glucose fluctuation (MAGE, SD), incidence of hypoglycemia, change of QOL
Key secondary outcomes fasting glucose level, daily insulin dose

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Insulin Glargine is replaced to insulin Degludec. CGM is performed before and immediately after replacement for 6 days.
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 1)HbA1c values 6.5%-12%
2)Patients medicated with insulin Glargine for more than 3 month
Key exclusion criteria 1)Patients with hypersensitivity to Degludec
2)Patients with severe renal or liver failure
3)Patients with proliferative diabetic retinopathy (except for stable condition by photocoagulation)
4)Patients who are pregnant or in lactation period
5)Patients who achieve good plasma glucose levels by treatment with insulin Glargine
6)Judged as ineligible by clinical investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Nakamura
Organization Aichi Medical University
Division name Division of Diabetes, Department of Internal Medicine, Diabetes Center
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-63-1683
Email jiro@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiro Kato
Organization Aichi Medical University
Division name Division of Diabetes, Department of Internal Medicine, Diabetes Center
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-63-1683
Homepage URL
Email ykato4@aichi-med-u.ac.jp

Sponsor
Institute Division of Diabetes, Department of Internal Medicine, Diabetes Center,Aichi Medical University
Institute
Department

Funding Source
Organization Division of Diabetes, Department of Internal Medicine, Diabetes Center,Aichi Medical University
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 11 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 01 Day
Last modified on
2014 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014264

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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