UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002995 |
|---|---|
| Receipt number | 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 21:37:41 |
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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
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
hiroki@yamanashi.ac.jp
Sponsor or person
Institute
Third Department of Intenal Medicine, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003180
