UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003142 |
|---|---|
| Receipt number | R000003810 |
| Scientific Title | Comparison of Voglibose and Acarbose on incretin secretion and postprandial metabolic parameters in type 2 diabetes |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2014/02/07 09:50:03 |
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Basic information
Public title
Comparison of Voglibose and Acarbose on incretin secretion and postprandial metabolic parameters in type 2 diabetes
Acronym
Comparison of Voglibose and Acarbose on incretin secretion and postprandial metabolism
Scientific Title
Comparison of Voglibose and Acarbose on incretin secretion and postprandial metabolic parameters in type 2 diabetes
Scientific Title:Acronym
Comparison of Voglibose and Acarbose on incretin secretion and postprandial metabolism
Region
| Japan |
Condition
Condition
type 2 diabetes patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of Voglibose and Acarbose on incretin secretion and postprandial metabolic parameters in type 2 diabetes patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incretin secretion and postprandial metabolic parameters after loading test meal
Key secondary outcomes
1)Change from baseline in glucose metabolism
2)Change from baseline in lipid metabolism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Voglibose 0.3mg
Interventions/Control_2
Acarbose 100mg
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age 18 to 80 years
2)Diabetes mellitus (HbA1c=<7.0%), Fasting glucose less than 140mg/dL
3)Patients with written informed concent
Key exclusion criteria
1) Previous use of alpha-glucosidase inhibitor, DPP-4 inhibitor, GLP-1 analog within 3 months
2)Severe ketosis, diabetic coma or diabetic precoma
3)Severe hepatic dysfunction or severe kidney dysfunction
4)Severe infection or serious trauma, perioperative patients or severe injury
5)Hypersensitivity to any ingredient of Voglibose or Acarbose
6)Severe neuropathy
7)Current treatment with steroid
8)Patients judged by the investigator to be ineligible for some other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Usuda Rika |
Organization
Toyama Prefectural Central Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
2-2-78 Nishinagae, Toyama city, Toyama
TEL
(076)424-1531
rika.u@po2.nsknet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Usuda Rika |
Organization
Toyama Prefectural Central Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
2-2-78 Nishinagae, Toyama city, Toyama
TEL
(076)424-1531
Homepage URL
rika.u@po2.nsknet.or.jp
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cell Metabolism and Nutrition Brain/Liver interface Medicine Research Center, Kanazawa University
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
富山県立中央病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 04 | 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
| 2010 | Year | 02 | Month | 07 | Day |
Last modified on
| 2014 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003810
| 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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| Registered date | File name |
