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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010474
Receipt No. R000012243
Scientific Title Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
Date of disclosure of the study information 2013/04/15
Last modified on 2014/05/16

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Basic information
Public title Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
Acronym JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 2
Scientific Title Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
Scientific Title:Acronym JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 2
Region
Japan

Condition
Condition twice-daily administration of basal insulin in type 1 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare insulin degludec with insulin glargine or insulin detemir for efficacy and safety in type 1 diabetic patients with twice-daily administration of basal insulin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of HbA1c level of the two treatment
Key secondary outcomes The difference between treatments in following parameters: fasting plasma glucose (FPG), variability (standard deviation) and intra individual variability of 7-point capillary blood glucose profile value measured by SMBG, variability of the two treatments by the continuous glucose monitoring system(Medtronic), frequency and severity of hypoglycemic episodes

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 twice-daily administration of basal insulin is replaced to insulin degludec in type 1 diabetes
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1)subjcets whose age are more than 20 years and under 80 years.

(2)no restriction on gender

(3)written informed consent was obtained from all subjects after they had been provided with sufficient information
about the study.
Key exclusion criteria 1.Patients with past medical history of hypersensitivity to Degludec.
2.Patients with serious liver,renal,pituitary and adrenal insufficiency.
3.Patients with diarrhea, vomiting and other gastrointestinal problems.
4.Patients with starvation state or unstable appetite.
5.Patients with serious diabetic complications including proliferative retinopathy.
6.Patients who are pregnant, hope to be pregnant, or are in lactation period.
7.Judged as ineligible by clinical investigators
8.Patients with type 1 diabetes
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuki Ikeda
Organization Juntendo University Graduate School of Medicine
Division name Dept. of Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL 03-3813-3111
Email fuki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuki Ikeda
Organization Juntendo University Graduate School of Medicine
Division name Dept. of Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL 03-3813-3111
Homepage URL
Email fuki@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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 04 Month 15 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 Completed
Date of protocol fixation
2013 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 15 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 04 Month 12 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012243

Research Plan
Registered date File name
2018/02/05 資料1 臨床研究実施計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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