UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009981 |
|---|---|
| Receipt number | R000007304 |
| Scientific Title | The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2013/08/06 16:27:05 |
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Basic information
Public title
The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Acronym
The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Scientific Title
The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Scientific Title:Acronym
The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of various oral hypoglycemic agents for glucose, insulin and gut-derived hormones.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of plasma glucose, insulin, GLP-1, GIP, glucagon, and ghrelin after meal tolerance test.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Acarbose 100mg
Interventions/Control_2
Migritol 50mg
Interventions/Control_3
Sitaguliptin 50mg
Interventions/Control_4
Control
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
Out patient of type 2 diabetes without medication. HbA1c level is less than 9%.
Key exclusion criteria
Type 1 diabetes, malignancy, infection, or severe liver or renal dysfunction.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
TEL
+81-985-85-2965
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Neurology, Respirology, Endocrinology and Metabolism,Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Sanwa kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 08 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2013 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007304
