UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007378 |
|---|---|
| Receipt number | R000008694 |
| Scientific Title | Effect of the glucagon suppression ability in the sulfonylurea agents and other oral hypoglycemic agents. |
| Date of disclosure of the study information | 2012/02/28 |
| Last modified on | 2013/02/27 11:58:12 |
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Basic information
Public title
Effect of the glucagon suppression ability in the sulfonylurea agents and other oral hypoglycemic agents.
Acronym
Effect of the glucagon suppression ability in the sulfonylurea agents and other oral hypoglycemic agents.
Scientific Title
Effect of the glucagon suppression ability in the sulfonylurea agents and other oral hypoglycemic agents.
Scientific Title:Acronym
Effect of the glucagon suppression ability in the sulfonylurea agents and other oral hypoglycemic agents.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diabetic patients who have poorly controlled glycemia with oral hypoglycemic agents are divided into two groups of patients who are taking sulfonylurea agents and other agents(except phenylalanine derivatives).
Glucagon levels and inslin levels in the blood are measured and the association between them is analyzed to assess the effect of sulfonylurea agents.Based on the result of this study,a guideline for use of sulfonylurea agents will be suggested.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
glucagon,glucagon/FPG ratio,glucagon/CPR ratio
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sulfonylurea agents
Interventions/Control_2
other hypoglycemic agents(except phenylalanine derivatives)
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
diabetic patients
The patient who does not have change in the cure for the past three months
Key exclusion criteria
The patient who has glucagonoma
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisamitsu Ishihara |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL
03-3972-8245
Homepage URL
Sponsor or person
Institute
Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
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
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
日本大学医学部附属板橋病院糖尿病代謝内科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 25 | Day |
Last modified on
| 2013 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008694
