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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039400
Receipt No. R000044922
Scientific Title Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2020/02/05
Last modified on 2020/02/05

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Basic information
Public title Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes
Acronym Lixisenatide on gastric emptying
Scientific Title Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes
Scientific Title:Acronym Lixisenatide on gastric 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 lixisenatide 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 Changes of the half gastric emptying time (T1/2) and the lag phase (Tlag) before and after lixisenatide 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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Lixisenatide therapy is initiated at 10 micro g daily, and the dose is increased to 20 micro g daily after 1 week.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria T2DM
Key exclusion criteria 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 Yasushi
Middle name
Last name Tanaka
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 0449778111
Email y2tanaka@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Nagai
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code 216-8511
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 Self funding
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 St. Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel 0449778111
Email k-sienbu.mail@marianna-u.ac.jp

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
2020 Year 02 Month 05 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 15
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 06 Month 16 Day
Date of IRB
2014 Year 07 Month 22 Day
Anticipated trial start date
2014 Year 07 Month 22 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 05 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044922

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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