UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009651 |
|---|---|
| Receipt number | R000011328 |
| Scientific Title | Efficacy of metformin or Metact in type 2 Japnese patients with diabetes |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2019/01/29 12:24:15 |
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Basic information
Public title
Efficacy of metformin or Metact in type 2 Japnese patients with diabetes
Acronym
Meatact study
Scientific Title
Efficacy of metformin or Metact in type 2 Japnese patients with diabetes
Scientific Title:Acronym
Meatact study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy between 100mg metformin and Metact(500mg metformin+15mg pioglitazone) in Japanese patients with type 2 diabetes who were in indequate blood glucose control with 500mg metformin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cervical IMT, HbA1c, serum adiponectin, serum osteopontin, PWV(pulse wave velocity)
Key secondary outcomes
body weight
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1000mg metformin
Interventions/Control_2
MetactLD
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese patinets with type 2 diabetes who are in inadequate blood glucose control with 500mg metformin
Key exclusion criteria
allergy for metformin or pioglitazone
renal failure
type1 diabetes
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Yanase |
Organization
Fukuoka university, school of medicine
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nomiyama |
Organization
Fukuoka university, school of medicine
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
Address
TEL
Homepage URL
tnomiyama@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes Mellitus, school of medicine, Fukuoka universty
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Diabetes Mellitus, school of medicine, Fukuoka universty
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 | 01 | Month | 01 | 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 | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011328
