UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011167 |
|---|---|
| Receipt number | R000013080 |
| Scientific Title | Efficacy and safety of switching from thrice daily glinide or alpha-GI to twice daily mitiglinide/voglibose combined drug in type 2 diabetes. |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2014/09/29 12:16:42 |
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Basic information
Public title
Efficacy and safety of switching from thrice daily glinide or alpha-GI to twice daily mitiglinide/voglibose combined drug in type 2 diabetes.
Acronym
Efficacy and safety of switching from thrice daily glinide or alpha-GI to twice daily mitiglinide/voglibose combined drug in type 2 diabetes.
Scientific Title
Efficacy and safety of switching from thrice daily glinide or alpha-GI to twice daily mitiglinide/voglibose combined drug in type 2 diabetes.
Scientific Title:Acronym
Efficacy and safety of switching from thrice daily glinide or alpha-GI to twice daily mitiglinide/voglibose combined drug in type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effectiveness and safety of the glycemic control and daily fluctuation of blood glucose between patients treated with present drug, thrice daily glinide or alpha-GI, and patients switched to twice daily mitiglinide/voglibose combined drug in type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of HbA1c (NGSP) from baseline
Key secondary outcomes
Base
Study type
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of mitiglinide/voglibose combination (twice daily)
Interventions/Control_2
Administration of glinide or alpha-GI (thrice daily)
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
1)The patients treated with diet therapy and glinide or alpha-GI of fixed dosage and administrated for eight weeks or longer before start of observation period.
2)The patients who can take fixed dosage and same medicine during the study, in case of being treated with combination therapy of oral hypoglycemic agents other than glinide or alpha-GI for eight weeks or longer before start of observation period.
3)The patients with HbA1c(NGSP) less than 8.4% (start of observation period and start of treatment period).
4)The patients who can measure SMBG.
5)The patients whose age are more than 20 years.
6)Outpatients.
Key exclusion criteria
1)The patients applicable to the contraindications of mitiglinide or voglibose.
2)The patients who are treated with combination therapy of gulinide and alpha-GI.
3)The patients who has an administration history of SU drug within eight weeks before start of observation period.
4)The patients who drink alcohol too much.
5)The patients complicated with severe diabetic microangiopathy.
6)The patients complicated with severe hepatic diseases or severe renal diseases.
7)The patients complicated with severe cardiac disease.
8)The patients complicated with severe hypertension.
9)The patients who are treated with GLP-1 analog or insulin, or the patients who need their treatment.
10)In addition, the patients whom researchers judged to be inappropriate to study participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Ohmura |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept.of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept.of Metabolism and Endocrinology
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 07 | Month | 18 | 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
This study was terminated due to a luck of enough subject persons.
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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2014 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013080
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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