UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009541 |
|---|---|
| Receipt number | R000011200 |
| Scientific Title | the comparison of glycemic control between sulfonylureas and repaglinide treated type 2 diabetic patients |
| Date of disclosure of the study information | 2012/12/13 |
| Last modified on | 2012/12/17 20:22:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
the comparison of glycemic control between sulfonylureas and repaglinide treated type 2 diabetic patients
Acronym
the comparison of efficacy(glycemic control) and safety
Scientific Title
the comparison of glycemic control between sulfonylureas and repaglinide treated type 2 diabetic patients
Scientific Title:Acronym
the comparison of efficacy(glycemic control) and safety
Region
| Japan |
Condition
Condition
type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the comparison of glycemic control between sulfonylureas and repaglinide in the type 2 diabetic patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the group A: sulfonylureas
Interventions/Control_2
the group B:the switch from sulfonylureas to repaglinide.twice-daily taking.
Interventions/Control_3
the group C:the switch from sulfonylureas to repaglinide.thrice-daily taking.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) taking sulfonylureas (less than half of maximum dose)
2) before registration-HbA1c<8.5% for 3 months or more
3) Age more than 20,less than 85
Key exclusion criteria
1) patients using insulin
2) patients with severe liver dysfunction
3) pregnant women
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aoki |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 13 | 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
| 2012 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
We will perform the interim analysis.
Management information
Registered date
| 2012 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011200
