UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011567 |
|---|---|
| Receipt number | R000013521 |
| Scientific Title | The efficancy of a new long-acting insulin degludec in patient with diabetes |
| Date of disclosure of the study information | 2013/08/31 |
| Last modified on | 2015/08/23 16:00:51 |
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Basic information
Public title
The efficancy of a new long-acting insulin degludec in patient with diabetes
Acronym
The efficancy of a new long-acting insulin degludec in patient with diabetes
Scientific Title
The efficancy of a new long-acting insulin degludec in patient with diabetes
Scientific Title:Acronym
The efficancy of a new long-acting insulin degludec in patient with diabetes
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare an new long-acting insulin degludec with the existing diabetes therapeutic drug for efficancy and safety in diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c and the score of Diabetes Treatment Satisfaction Questionnaire and dietary behavior Questionnaire , ITNA-1 and adverse events including hypoglycemia at 24 weeks later from an examination start
Key secondary outcomes
From an examination start, it is the following items 48 weeks later for up to 24 weeks.
-Achievement rate of HbA1c <7.0% and <8.0%
-Change in fasting blood glucose
-Glycemic variability by CGM and SMBG
-Change in insulin dose(daily basal insulin doses, daily total insulin doses)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
insulin degludec
Interventions/Control_2
Continuing with the treatment so far
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HbA1c :more than 8.0%
Key exclusion criteria
Contraindicated patient in the attached document of insulin degludec
Contraindicated patient in the attached document of diabetes drugs
Hypoglycemic risk
Serious heart trouble
Severe hepatic dysfunction
Severe renal dysfunction
Internal secretion disease
Needs the steroid dosage
Patients judged by the investigator to be ineligible for some other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yasuda |
Organization
Osaka Saiseikai Noe Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL
06-6932-0401
kyasuda@noe.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoya Koie |
Organization
Osaka Saiseikai Noe Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL
06-6932-0401
Homepage URL
motoya.koie@noe.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Noe Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Saiseikai Noe Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
大阪府済生会野江病院（大阪府） /Osaka Saiseikai Noe Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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 | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
