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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010341
Receipt No. R000012108
Scientific Title Effects of liraglutide on gastric emptying in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2013/03/28
Last modified on 2014/02/28

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Basic information
Public title Effects of liraglutide on gastric emptying in Japanese patients with type 2 diabetes
Acronym VictOza and Gastric [U] Emptying
Scientific Title Effects of liraglutide on gastric emptying in Japanese patients with type 2 diabetes
Scientific Title:Acronym VictOza and Gastric [U] Emptying
Region
Japan

Condition
Condition T2DM
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of liraglutide on gastric emptying using 13C acetate breath test
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The half gastric emptying time (T1/2) and the lag phase (Tlag) before and after liraglutide treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Liraglutide therapy is initiated at 0.3 mg daily, and the dose is increased by 0.3 mg every 3 days to 0.9 mg.
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria T2DM
Key exclusion criteria T1DM

Patients who are judged by investigators to be inappropriate for inclusion in this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email y2tanaka@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Nagai
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email ynagai@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
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
2013 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/dom.12247/abstract
Number of participants that the trial has enrolled
Results This study was performed to clarify the influence of liraglutide on gastric emptying in Japanese patients with type 2 diabetes. In 16 patients, the [13C]-acetate breath test was performed to compare gastric emptying before and after liraglutide treatment. We found two patterns of response, with gastric emptying being delayed by liraglutide in seven patients (delayers) and not delayed in nine patients (non-delayers). The effect of liraglutide treatment on gastric emptying shows heterogeneity, and patients can be classified as delayers or non-delayers.
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
2011 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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

Management information
Registered date
2013 Year 03 Month 28 Day
Last modified on
2014 Year 02 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012108

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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