UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010067
Receipt number R000011694
Scientific Title GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Date of disclosure of the study information 2013/04/01
Last modified on 2017/08/03 17:04:58

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Basic information

Public title

GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment

Acronym

GLP-1 administration test

Scientific Title

GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment

Scientific Title:Acronym

GLP-1 administration test

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 purposes of this clinical trial are to assess the GLP-1 administration test reflects the insulin secretion capacity and predicts the efficacy of incretin based treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Insulin secretion in GLP-1 administration compared to saline administration using meal tolerance test.
2. The relationship between the result of GLP-1 administration test and the changes of HbA1c after incretin based treatment.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

GLP-1

Interventions/Control_2

saline

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Diabetes mellitu type 2 without using incretin based drugs.

Key exclusion criteria

Patient with severe complication (proliferative retinopathy, serum cleatinine > 2.0 mg/dL, cerebrovascular disease, and/or ischemic heart diseases), severe liver dysfunction and/or dementia.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masamitsu Nakazato

Organization

Miyazaki university, fuculty of medicine

Division name

Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ueno

Organization

Miyazaki university, fuculty of medicine

Division name

Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine

Zip code


Address


TEL


Homepage URL


Email

intron@med.miyazaki-u.ac.jp


Sponsor or person

Institute

Miyazaki university

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 04 Month 01 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

Terminated

Date of protocol fixation

2012 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2017 Year 08 Month 03 Day

Date of closure to data entry


Date trial data considered complete

2017 Year 08 Month 03 Day

Date analysis concluded

2017 Year 08 Month 03 Day


Other

Other related information



Management information

Registered date

2013 Year 02 Month 18 Day

Last modified on

2017 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name