UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004193
Receipt number R000005037
Scientific Title Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)
Date of disclosure of the study information 2010/09/22
Last modified on 2012/03/11 18:04:28

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Basic information

Public title

Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)

Acronym

Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)

Scientific Title

Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)

Scientific Title:Acronym

Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of metformin and lifestyle interventions as an initial treatment in newly diagnosed Japanese patients with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in glycated hemoglobin (HbA1c) at 16 weeks after the initiation of the treatment

Key secondary outcomes

Change in body weight, fasting plasma glucose, glycated albumin, total cholesterol, triglyceride, HDL-cholesterol, liver enzymes, and an incidence of adverse effects during treatment.


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

Newly diagnosed patients with type 2 diabetes aged 20 years and older.

Key exclusion criteria

Type 1 diabetes.
Patients contraindicated to metformin.
Patients judged not to be eligible by the principal investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoru Sumitani

Organization

Nissay Hospital

Division name

Center for Preventive Medicine

Zip code


Address

6-3-8 Itachibori, Nishi-ku, Osaka, Osaka

TEL

06-6543-3581

Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoru Sumitani

Organization

Nissay Hospital

Division name

Center for Preventive Medicine

Zip code


Address

6-3-8 Itachibori, Nishi-ku, Osaka, Osaka

TEL

06-6543-3581

Homepage URL


Email

sa_sumitani@yahoo.co.jp


Sponsor or person

Institute

Nissay Hospital

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


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

日本生命済生会付属日生病院(大阪府)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://medical.med.tokushima-u.ac.jp/jmi/vol59/pdf/v59_n1-2_p166.pdf

Number of participants that the trial has enrolled


Results

Satoru Sumitani, Shinya Morita, Yoshihiko Utsu, Kosuke Mukai, Shunji Miki, Bunzo Sato, Hideji Nakamura, Soji Kasayama. Effectiveness of metformin and lifestyle interventions asan initial treatment in Japanese patients with newly diagnosed type 2 diabetes : a prospective observational study. J. Med. Invest. 59 : 166-173, February, 2012

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 09 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A cohort study


Management information

Registered date

2010 Year 09 Month 11 Day

Last modified on

2012 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005037


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name