UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006860
Receipt number R000007418
Scientific Title Initial pharmacological therapies for newly diagnosed, drugs naïve patients with type 2 diabetes
Date of disclosure of the study information 2011/12/15
Last modified on 2012/06/08 17:23:53

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Basic information

Public title

Initial pharmacological therapies for newly diagnosed, drugs naïve patients with type 2 diabetes

Acronym

First-line therapy for T2DM

Scientific Title

Initial pharmacological therapies for newly diagnosed, drugs naïve patients with type 2 diabetes

Scientific Title:Acronym

First-line therapy for T2DM

Region

Japan


Condition

Condition

T2DM

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the best initial therapeutic option for newly diagnosed, drug naive subjects with T2DM (depending upon the characteristics of the backgrounds of the subjects)

Glycemic and non-glycemic efficacy and safety of several oral hypoglycemic drugs with newly diagnosed, drug naïve subjects 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

HbA1, FBG,

Key secondary outcomes

indexes for beta-cell function and insulin sensitivity, lipid parameters, body weight, blood pressure,


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Behavior,custom

Interventions/Control_1

several oral hypoglycmeic drugs

Interventions/Control_2

diet/exercise

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

hepatic/renal/cardiac/hypertensive disorder
pregnant women

Key exclusion criteria

hepatic/renal/cardiac/hypertensive disorder
pregnant women

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Kutoh

Organization

Biomedical Center

Division name

Clinical Research

Zip code


Address

1-5-8-613 Komatsugawa, Edogawa, Tokyo, Japan

TEL

090-6304-9638

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Biomedical Center

Division name

Clinical Research

Zip code


Address


TEL


Homepage URL


Email

ekuto@excite.com


Sponsor or person

Institute

Biomedical Center

Institute

Department

Personal name



Funding Source

Organization

Biomedical Center

Organization

Division

Category of Funding Organization

Other

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

2011 Year 12 Month 15 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 01 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2011 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 12 Month 08 Day

Last modified on

2012 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name