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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003142
Receipt No. 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

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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
Email 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
Email rika.u@po2.nsknet.or.jp

Sponsor
Institute Toyama Prefectural Central Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003810

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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