UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010067 |
|---|---|
| Receipt number | R000011694 |
| Scientific Title | GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/08/03 17:04:58 |
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Basic information
Public title
GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Acronym
GLP-1 administration test
Scientific Title
GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Scientific Title:Acronym
GLP-1 administration test
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this clinical trial are to assess the GLP-1 administration test reflects the insulin secretion capacity and predicts the efficacy of incretin based treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Insulin secretion in GLP-1 administration compared to saline administration using meal tolerance test.
2. The relationship between the result of GLP-1 administration test and the changes of HbA1c after incretin based treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
GLP-1
Interventions/Control_2
saline
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetes mellitu type 2 without using incretin based drugs.
Key exclusion criteria
Patient with severe complication (proliferative retinopathy, serum cleatinine > 2.0 mg/dL, cerebrovascular disease, and/or ischemic heart diseases), severe liver dysfunction and/or dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
Miyazaki university, fuculty of medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Miyazaki university, fuculty of medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki university
Institute
Department
Personal name
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
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 | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011694
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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