UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011071
Receipt number R000012960
Scientific Title Clinical efficacy of anagliptin administration in type 2 diabetic patients
Date of disclosure of the study information 2013/06/29
Last modified on 2013/06/29 01:08:59

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Basic information

Public title

Clinical efficacy of anagliptin administration in type 2 diabetic patients

Acronym

Clinical efficacy of anagliptin administration in type 2 diabetic patients

Scientific Title

Clinical efficacy of anagliptin administration in type 2 diabetic patients

Scientific Title:Acronym

Clinical efficacy of anagliptin administration in type 2 diabetic patients

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of anagliptin on glycemic control,fat,renal function and heart function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Glycemic control,fat,renal function and heart function after treatment with anagliptin.

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

Newly-diagnosed type 2 diabetic patients with inadequate glycemic control on diet and exercise
Type 2 diabetic patients being treated with oral hypoglycemic agent,whose differences of HbA1c(measured continuously at intervals of one month or more) are less than 0.5%
1)HbA1c:more than 6.0% less than 10.0%
2)Age:more than 20 years(at the time of informed consent date)
3)No restriction on gender
4)Ability to provide written informed consent for this study

Key exclusion criteria

Out of above criteria

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Setsuya Okubo

Organization

Kuwana East Medical Center

Division name

Cardiology

Zip code


Address

3-11 Kotobuki Kuwana,Mie,Japan

TEL

0594-22-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Setsuya Okubo

Organization

Kuwana East Medical Center

Division name

Department of Cardiology

Zip code


Address

3-11 Kotobuki Kuwana,Mie,Japan

TEL

0594-22-1211

Homepage URL


Email



Sponsor or person

Institute

Kuwana East Medical Center Cardiology

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



Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 29 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

Enrolling by invitation

Date of protocol fixation

2013 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 07 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

We have expected that there are the same Clinical Effect of anagliptin compared with Other DPP4-inhibitor agent.


Management information

Registered date

2013 Year 06 Month 29 Day

Last modified on

2013 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012960


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name