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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011567
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email motoya.koie@noe.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Noe Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013521


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