UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016011 |
|---|---|
| Receipt number | R000018610 |
| Scientific Title | The comparison of alfa glucosidase inhibitor or glinide based DPP-4 inhibitor combination therapy in drug-naive type 2 diabetic patients. |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2014/12/19 19:01:18 |
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Basic information
Public title
The comparison of alfa glucosidase inhibitor or glinide based DPP-4 inhibitor combination therapy in drug-naive type 2 diabetic patients.
Acronym
The comparison of alfa GI or glinide based DPP-4 inhibitor combination therapy
Scientific Title
The comparison of alfa glucosidase inhibitor or glinide based DPP-4 inhibitor combination therapy in drug-naive type 2 diabetic patients.
Scientific Title:Acronym
The comparison of alfa GI or glinide based DPP-4 inhibitor combination therapy
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the efficacy of alfa GI or glinide based DPP-4 inhibitor additional therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycemic control improvement effect and hypoglycaemic attack frequency
Key secondary outcomes
postprandial serum glucose and lipids improvement effect, change of the serum insulin and incretin level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
miglitol 150mg and alogliptin 25mg
Interventions/Control_2
repaglinide 0.75mg and alogliptin 25mg
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient treated with only a dietetic therapy more than three months with the value of HbA1c more than 7.0% less than 9.0%.
Key exclusion criteria
An antidiabetic is given.
The patient have serious liver dysfunction.
The patient have moderate or severe renal dysfunction.
The patient have a malignant tumor.
The patient become pregnant or may become pregnant.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumitaka Okajima |
Organization
Nippon Medical School Choba Hokusoh Hospital
Division name
Division of Endocrinology
Zip code
Address
1715 Kamakari, Inzai, Chiba
TEL
0476-99-1111
okaji@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumitaka Okajima |
Organization
Nippon Medical School Choba Hokusoh Hospital
Division name
Division of Endocrinology
Zip code
Address
1715 Kamakari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
okaji@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Grans-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 12 | Month | 19 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 16 | 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
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018610
