UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016861 |
|---|---|
| Receipt number | 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 11:20:08 |
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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
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
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019572
