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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003561
Receipt No. R000004084
Scientific Title Multi-centered Liraglutide observational study by CGMS in West-Tokyo area
Date of disclosure of the study information 2010/10/15
Last modified on 2010/05/02

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Basic information
Public title Multi-centered Liraglutide observational study by CGMS in West-Tokyo area
Acronym Liraglutide observational CGMS study
Scientific Title Multi-centered Liraglutide observational study by CGMS in West-Tokyo area
Scientific Title:Acronym Liraglutide observational CGMS study
Region
Japan

Condition
Condition Type2 diabetes
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the change of glycemic control by CGMS before and 2 month after Liraglutide administration and 2 months after withdrawal of Liraglutide.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time of blood glucose more than 180mg/dl, and less than 70mg/dl, mean blood glucose, max and minimum blood glucose, standard deviation of blood glucose and its change.
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

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 30

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
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
Institute Tama-center Mirai Clinic
Institute
Department

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 Time of blood glucose more than 180mg/dl, and less than 70mg/dl, mean blood glucose, max and minimum blood glucose, standard deviation of blood glucose and its change is considered to be improved after administration of Liraglutide.

Management information
Registered date
2010 Year 05 Month 02 Day
Last modified on
2010 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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