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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010467
Receipt No. R000012235
Scientific Title Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/04/11
Last modified on 2022/01/21

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Basic information
Public title Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Acronym Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Scientific Title Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postprandial glucose and insulin level after the meal tolerance test, IMT, PWV
Key secondary outcomes

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 Non-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
Interventions/Control_1 glinide
Interventions/Control_2 sulfonylurea
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria HbA1c>6.5%
Key exclusion criteria Renal failure, Liver dysfunction
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okura
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address 36-1 Nishi-Cho
TEL 0859386517
Email ohkura@tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okura
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address 36-1 Nishi-Cho
TEL 0859386517
Homepage URL
Email ohkura@tottori-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
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 Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 11 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 No longer recruiting
Date of protocol fixation
2006 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 27 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 04 Month 11 Day
Last modified on
2022 Year 01 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012235


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