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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010715
Receipt No. R000012525
Scientific Title Comparison of insulin glargine and insulin degludec in type 2 diabetes by continuous glucose monitoring system
Date of disclosure of the study information 2013/05/15
Last modified on 2013/11/29

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Basic information
Public title Comparison of insulin glargine and insulin degludec in type 2 diabetes by continuous glucose monitoring system
Acronym Comparison of insulin glargine and insulin degludec in type 2 diabetes by continuous glucose monitoring system
Scientific Title Comparison of insulin glargine and insulin degludec in type 2 diabetes by continuous glucose monitoring system
Scientific Title:Acronym Comparison of insulin glargine and insulin degludec in type 2 diabetes by continuous glucose monitoring system
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare insulin degludec with insulin glargine for safety and efficacy in type 2 diabetes by continuous glucose monitoring system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes glycemic variability by continuous glucose monitoring system
Key secondary outcomes BMI,HbA1c,glycated albumin,1,5-AG

QOL(ITR-QOLN),

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
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 Device,equipment
Interventions/Control_1 Glargine 8week, Degludec 8week
Week8,16CGM
Interventions/Control_2 Degludec 8week, Glargine 8week
Week8,16CGM
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)type 2 diabetes
outpatient
once daily Insulin Glargine administrated before dinner or bed time
Basal Bolus therapy or Basal supported oral therapy

(2)HbA1c: <8.4%
Key exclusion criteria (1)patient with poor glycemic control

(2)Type 1 diabetes

(3)secondary diabetes

(4)unstable diabetic complication
active proliferative retinopaty
untreated cardiovascular disease
(5) Patient hospitalized or changed treartment within three months


(6) noncompliance
Irregular life (Night shift pursuer)
(7)not willing to use CGM, SMBG

(8)Judged as ineligible by clinical investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Tanaka
Organization Mie Chuo Medical Center
Division name Internal medicine
Zip code
Address 2158-5 Hisaimyojincho Tsu City, Mie, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mie Chuo Medical Center
Division name Internal medicine
Zip code
Address 2158-5 Hisaimyojincho Tsu City, Mie, Japan
TEL
Homepage URL
Email

Sponsor
Institute Mie Chuo Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ise Red Cross Hospital
National Mie Hospital
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 05 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 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 05 Month 14 Day
Last modified on
2013 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012525

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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