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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011167
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013080

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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