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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002995
Receipt No. R000003180
Scientific Title Randomized study comparing effects of oral hypoglycemic agents (nateglinide, acarbose) on daily glucose profile analyzed by 24-hour continuous glucose monitering system
Date of disclosure of the study information 2010/01/07
Last modified on 2010/01/07

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Basic information
Public title Randomized study comparing effects of oral hypoglycemic agents (nateglinide, acarbose) on daily glucose profile analyzed by 24-hour continuous glucose monitering system
Acronym Randomized study comparing effects of oral hypoglycemic agents with CGMS
Scientific Title Randomized study comparing effects of oral hypoglycemic agents (nateglinide, acarbose) on daily glucose profile analyzed by 24-hour continuous glucose monitering system
Scientific Title:Acronym Randomized study comparing effects of oral hypoglycemic agents with CGMS
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Alpha-glucosidase inhibitors (acarbose, et al.) and glinides (nateglinide, et al.) have favorable effects against postprandial hyperglycemia. We measure the daily profile of blood glucose level by continuous glucose monitering (CGM) system in patients of type 2 diabetes treated by acarbose or nateglinide. By the analysis of the CGM results and several laboratory data, we investigate the methods to predict the effects of acarbose and nateglinide.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Daily profiles of glucose level in patients to whom acarbose or nateglinide is administered.
Key secondary outcomes

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CGM for three days.
Day 1 : no medication
Day 2: acarbose 100mg 3 times in a day
Day 3: nateglinide 90mg 3 times in a day
Interventions/Control_2 CGM for three days.
Day 1 : no medication
Day 2: nateglinide 90mg 3 times in a day
Day 3: acarbose 100mg 3 times in a day
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient with type 2 insulin-independent diabetes with level of HbA1c between 6.5 and 9%.
Key exclusion criteria 1. Severe ketosis, diabetic coma or semicoma
2. Severe infectious disease, pre- or post-surgical operation, severe injury.
3. Allergy to acarbose or nateglinide
4. Pregnant or lactation period
5. Sever liver or kidney failure
6. Overt obesity (BMI>40)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Kobayashi
Organization University of Yamanashi
Division name Third Department of Internal Medicine
Zip code
Address 1110 Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-9685
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Shimura
Organization University of Yamanashi
Division name Third Department of Internal Medicine
Zip code
Address 1110 Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-9602
Homepage URL
Email hiroki@yamanashi.ac.jp

Sponsor
Institute Third Department of Intenal Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 山梨大学医学部附属病院(山梨県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 07 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 Open public recruiting
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 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 01 Month 07 Day
Last modified on
2010 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003180

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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