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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016861
Receipt No. R000019572
Scientific Title Analysis of effect of mosapride citrate administration on increasing in type 2 diabetic patient's postprandial plasma active glucagon-like peptide-1
Date of disclosure of the study information 2015/03/21
Last modified on 2019/02/11

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Basic information
Public title Analysis of effect of mosapride citrate administration on increasing in type 2 diabetic patient's postprandial plasma active glucagon-like peptide-1
Acronym Effect of mosapride citrate in type 2 diabetic patient's GLP-1
Scientific Title Analysis of effect of mosapride citrate administration on increasing in type 2 diabetic patient's postprandial plasma active glucagon-like peptide-1
Scientific Title:Acronym Effect of mosapride citrate in type 2 diabetic patient's GLP-1
Region
Japan

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

Objectives
Narrative objectives1 To reveal the effect of mosapride citrate on increasing type 2 diabetic patient's postprandial plasma active GLP-1
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Difference between 2 groups' amount of 60 minutes postprandial plasma active GLP-1 change after 2 weeks administration of test drug or comparative drug from baseline
Key secondary outcomes Difference of 60 minutes postprandial plasma active GLP-1 change between before and after 2 weeks administration of test drug or comparative drug and difference between 2 groups' of glycoalbmin, 60 minutes postprandial insulin, glucose, HOMA-R, HOMA-beta, and frequency of stool

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 60 min postprandial blood withdrawal
Test drug (mosapride citrate) 15mg/day for 2 weeks
60 min postprandial blood withdrawal
Washout period (4-8 weeks)
60 min postprandial blood withdrawal
Comparative drug (dompridone) 30mg/day for 2 weeks
60 min postprandial blood withdrawal
Interventions/Control_2 60 min postprandial blood withdrawal
Comparative drug (dompridone) 30mg/day for 2 weeks
60 min postprandial blood withdrawal
Washout period (4-8 weeks)
60 min postprandial blood withdrawal
Test drug (mosapride citrate) 15mg/day for 2 weeks
60 min postprandial blood withdrawal
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetic patients
2) Glycoalbmin < 26.0 %
3) BMI < 30.0
4) Patient explained and informed with the written consent
Key exclusion criteria 1) Type 1 diabetic patients
2) Patient with a history of diabetic coma within 6 months
3) Necessity of insulin such as severe infection, perioperative period, and severe external injury
4) Severe hepatic and renal disorder (Ccr < 30mL/min, serum Cre > 2.0 mg/dl (female), 2.5 mg/dl (male), Child-Pugh grade C)
5) Severe gastrointestinal dysfunction
6) Patient administrated drugs with the same indications of test drug or comparative drug, insulin GLP-1 analog, or DPP4 inhibitor, or treated by 4 or more diabetes drug
7) Pregnant female, lactating female, or female with possibility or planning of pregnancy
9) Patients evaluated incompetent by doctors in attendance
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Maruoka
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Homepage URL
Email maruoka-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba 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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 21 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
2015 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2015 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

Management information
Registered date
2015 Year 03 Month 21 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019572

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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