UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003906
Receipt number R000004700
Scientific Title Establishment of novel glucose tolerance marker in diabetes patients.
Date of disclosure of the study information 2010/07/14
Last modified on 2011/07/07 09:26:16

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Basic information

Public title

Establishment of novel glucose tolerance marker in diabetes patients.

Acronym

Establishment of novel glucose tolerance marker in diabetes patients.(EAGLE study)

Scientific Title

Establishment of novel glucose tolerance marker in diabetes patients.

Scientific Title:Acronym

Establishment of novel glucose tolerance marker in diabetes patients.(EAGLE study)

Region

Japan


Condition

Condition

Type 2Diabetes Mellitus

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish of novel glucose tolerance marker in diabetes patients

Basic objectives2

Others

Basic objectives -Others

Changes in several biomarkers

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in several biomarkers from baseline after treatment of diabetes

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

(1)Patients with type 2 diabetes mellitus who have not treated or recieved medication and are to start medication or those who have been treated by alpha-glucosidase inhibitors and are to start medication by agents other than alpha-glucosidase inhibitors
(2)Women who are unlikely to conceive
(3)Patients who can visit in fasting condition for blood sampling
(4)Patients who voluntarily provide informed consent with enough comprehension after receiving enough explanation of this study

Key exclusion criteria

(1)Type 1 diabetes mellitus
(2)HbA1c>=8.0%
(3)Patients with no apparent history of diabetic nephropathy, diabetic retinopathy or diabetic neuropathy
(4)Patients with no history of malignancy
(5)Patients with no history of serious liver disease(i.e.acute hepatitis, acute exacerbation of chronic hepatitis, hepatocirrhosis, hepatoma,jaundice,biliary obstruction)
(6)Serum creatinine>=2.5mg/dl
(7)Under 20 years old
(8)Patients judged to be inappropriate for this study by the investigators

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Suzuki

Organization

Chu-NET

Division name

Owariasahi Clinic

Zip code


Address

2505-1 Harada, Higashi-daido-cho, Owariasahi, Aichi 488-0801, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Chu-NET

Division name

Office

Zip code


Address


TEL


Homepage URL


Email

chunet-office@umin.ac.jp


Sponsor or person

Institute

Chu-NET

Institute

Department

Personal name



Funding Source

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

2010 Year 07 Month 14 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

Completed

Date of protocol fixation

2010 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2010 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

completed


Management information

Registered date

2010 Year 07 Month 13 Day

Last modified on

2011 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004700


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name