UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007619 |
|---|---|
| Receipt number | R000008996 |
| Scientific Title | Efficacy and safety of glycemic control in type 2 diabetes patients when switched to mitiglinide/voglibose fixed-dose combination therapy. |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/10/10 11:12:12 |
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Basic information
Public title
Efficacy and safety of glycemic control in type 2 diabetes patients when switched to mitiglinide/voglibose fixed-dose combination therapy.
Acronym
Efficacy and safety of mitiglinide/voglibose fixed-dose combination therapy.
Scientific Title
Efficacy and safety of glycemic control in type 2 diabetes patients when switched to mitiglinide/voglibose fixed-dose combination therapy.
Scientific Title:Acronym
Efficacy and safety of mitiglinide/voglibose fixed-dose combination therapy.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change in HbA1c and %MPR in patients with type 2 diabetes switched from co-administration of a glinide and alpha glycosidase inhibitor to mitiglinide/voglibose fixed-dose combination tablet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
%MPR, HbA1c
Key secondary outcomes
1,5-AG, glycoalbumin, serum lipid profile, blood pressure, body weight, hypoglycemia, liver function, DTSQ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from co-administration of a glinide and alpha glycosidase inhibitor to mitiglinide/voglibose fixed dose combination tablet for 16 weeks.
Interventions/Control_2
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
Subjects with type 2 diabetes who are receiving a combination therapy with glinide and alpha glucosidase inhibitor more than 2 months.
Key exclusion criteria
1) Contraindicated for mitiglinide or voglibose.
2) Patients who received glinide or alpha GI more than daily dose*.
(Daily dose:
mitiglinide 10mg/time,
nateglinide 90mg/time,
voglibose 0.3mg/time,
acarbose 100mg/time,
miglitol 50mg/time)
3) Patients who had been previously receiving DPP4 inhibitor or GLP-1 analogue, insulin.
4) Anticipated to be non-compliant to the trial by principal investigators opinion.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University School of Medicine
Division name
Department of Nephrology, Endocrinology and Metabolism
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University School of Medicine
Division name
Department of Nephrology, Endocrinology and Metabolism
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Department of Nephrology, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008996
