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Recruitment status Completed
Unique ID issued by UMIN UMIN000014097
Receipt No. R000016410
Scientific Title Effect of liraglutide on lipid profile in patients with type 2 diabetes
Date of disclosure of the study information 2014/05/28
Last modified on 2019/03/25

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Basic information
Public title Effect of liraglutide on lipid profile in patients with type 2 diabetes
Acronym Effect of liraglutide on lipid profile
Scientific Title Effect of liraglutide on lipid profile in patients with type 2 diabetes
Scientific Title:Acronym Effect of liraglutide on lipid profile
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invetigate the mechanism of lipid lowering effect of liraglutide
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL-cholesterol
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes(HbA1c>=6.5%)
Key exclusion criteria Patients with severe renal disfunction
Patients with severe liver disfunction
Pregnant or lactating patients
Patients with obstruction of the intestines
Patients with pancreatitis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aoki
Organization Yokohama City University Hospital
Division name Department of Biostatistics and Epidemiology
Zip code
Address Fuku-ura 3-9, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2800
Email aokikazu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Aoki
Organization Yokohama City University Hospital
Division name Department of Biostatistics and Epidemiology
Zip code
Address Fuku-ura 3-9, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2800
Homepage URL
Email aokikazu@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Yokohama City University
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
2014 Year 05 Month 28 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
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We evaluate the effect of liraglutide on serum lipid profiles, including cholesterol synthesis and absorption markers, in Japanese patients with type 2 diabetes.

Management information
Registered date
2014 Year 05 Month 28 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016410


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