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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007378
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008694

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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