UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003560
Receipt number R000004083
Scientific Title Multi-centered Liraglutide add-on SU or diet alone study in West-Tokyo area
Date of disclosure of the study information 2010/10/15
Last modified on 2010/05/02 13:07:46

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Basic information

Public title

Multi-centered Liraglutide add-on SU or diet alone study in West-Tokyo area

Acronym

Liraglutide study adding-on SU or diet alone

Scientific Title

Multi-centered Liraglutide add-on SU or diet alone study in West-Tokyo area

Scientific Title:Acronym

Liraglutide study adding-on SU or diet alone

Region

Japan


Condition

Condition

Type2 diabetes

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)To observe of its safety and effectiveness
2)To observe HbA1c improvement 6 months after the administration of Liraglutide
3)To observe the difference of effectiveness between SUs.
4) To observe the control after withdrawal of Liraglutide.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c

Key secondary outcomes

Body weight, achievement of the goal, pancreas function, medications, AE, withdrawal rate, blood pressure, waist circumference, cholesterols, QOL


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Injection of Liraglutide, withdrawal of Liraglutide after achievement of glycemic control HbA1c<6.1%.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

HbA1c more than 6.5%, Type 2 diabetes, diet and exercise alone or prescribed surfonyl urea, 20 year-old or older, capable of injecting by themselves.

Key exclusion criteria

Serious hypoglycemia, serious diabetic retinopathy, serious heart failure, with malignant tumor, pregnant, prescribed TZD or glinide.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takaichi Miyakawa, Yuko Watanabe, Hitomi Fujii

Organization

Tama-center Mirai Clinic

Division name

Internal Medicine

Zip code


Address

1-38-1F Ochiai Tama-city, Tokyo

TEL

042-316-8570

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takaichi Miyakawa, Yuko Watanabe, Hitomi Fujii

Organization

Tama-center Mirai Clinic

Division name

Internal Medicine

Zip code


Address

1-38-1F Ochiai Tama-city, Tokyo

TEL

042-316-8570

Homepage URL


Email

irb-mirai@tama-mirai.com


Sponsor or person

Institute

Tama-center Mirai Clinic

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

2010 Year 10 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

Preinitiation

Date of protocol fixation

2010 Year 04 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

HbA1c and also the influence over body weight, serum cholesterol, and blood pressure will be observed. Also withdrawal rate and glycemic control after achievement HbA1c less than 6.1% will be observed.


Management information

Registered date

2010 Year 05 Month 02 Day

Last modified on

2010 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name