UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018271 |
|---|---|
| Receipt number | R000021148 |
| Scientific Title | The comparative study of the impact of differences in the timing of oral metformin hydrochloride in type 2 diabetes is on the glycemic control. |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2017/12/08 14:10:51 |
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Basic information
Public title
The comparative study of the impact of differences in the timing of oral metformin hydrochloride in type 2 diabetes is on the glycemic control.
Acronym
Oral timing of metformin hydrochloride
Scientific Title
The comparative study of the impact of differences in the timing of oral metformin hydrochloride in type 2 diabetes is on the glycemic control.
Scientific Title:Acronym
Oral timing of metformin hydrochloride
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The difference in the timing of oral metformin hydrochloride is a comparative study on the effects on glycemic control in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Differences of oral timing
Interventions/Control_2
Differences of oral timing
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c of 7.5% or less.
Key exclusion criteria
What you are using three or more agents of oral hypoglycemic agents other than metformin formulation.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Fukui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-251-5506
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muhei Tanaka |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-251-5506
Homepage URL
muhei-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 03 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | 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
| 2015 | Year | 07 | Month | 10 | Day |
Last modified on
| 2017 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021148
