UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011626 |
|---|---|
| Receipt number | R000013598 |
| Scientific Title | Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2018/09/05 17:28:40 |
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Basic information
Public title
Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Acronym
Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Scientific Title
Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the difference efficacy and safety between twice-daily taking and thrice-daily taking of high dose metformin in patients with type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diurnal glycemic profiles
Key secondary outcomes
Continuous Glucose Monitoring
Frequency of hyperglycemia
Lactate Level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: Twice-daily taking in first half part
Metformin is increased to 1500mg/day. Twice-daily taking are taken continuous over 4 days in first half part and thrice-daily taking are taken continuous over 4 days in second half part. Diurnal glycemic profiles are evaluated by SMBG(self-monitoring of blood glucose) and CGM(continuous glucose monitoring).
Interventions/Control_2
Group B: thrice-daily taking in first half part
Metformin is increased to 1500mg/day. Thrice-daily taking are taken continuous over 4 days in first half part and twice -daily taking are taken continuous over 4 days in second half part. Diurnal glycemic profiles are evaluated by SMBG(self-monitoring of blood glucose) and CGM(continuous glucose monitoring).
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 with type 2 diabetes who are in hospital for glycemic control.
2. Less than 1500mg/day of metformin
3. The patients who have agreed to participate in this study with an informed consent.
4.Age more than 20
Key exclusion criteria
1. Type 1 diabetes
2. Patients contraindicated to metformin
3. Patients judged not to be eligible by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ikegami |
Organization
Kinki University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Diabetes
Zip code
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
+81-72-366-0221(ext.3125)
ikegami@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Hiromine |
Organization
Kinki University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Diabetes
Zip code
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
+81-72-366-0221(ext.3125)
Homepage URL
hiromine@med.kindai.ac.jp
Sponsor or person
Institute
Department of Endocrinology, Metabolism, and Diabetes
Kinki University School of Medicine
Institute
Department
Personal name
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
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
近畿大学医学部附属病院（大阪府
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 09 | 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
| 2013 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013598
