UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010715 |
|---|---|
| Receipt number | 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 16:45:46 |
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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
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
Sponsor or person
Institute
Mie Chuo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012525
