UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040854 |
|---|---|
| Receipt number | R000046646 |
| Scientific Title | Effects of Metformin on Japanese type 2 diabetes patients: a retrospective study: METRO study |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2020/06/22 17:24:06 |
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Basic information
Public title
Effects of Metformin on Japanese type 2 diabetes patients: a retrospective study: METRO study
Acronym
Effects of Metformin on Japanese type 2 diabetes patients: a retrospective study: METRO study
Scientific Title
Effects of Metformin on Japanese type 2 diabetes patients: a retrospective study: METRO study
Scientific Title:Acronym
Effects of Metformin on Japanese type 2 diabetes patients: a retrospective study: METRO study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine that the therapeutic effects of metformin after 24 weeks in patients with type 2 diabetes who were prescribed metformin due to the difference in the timing of the introduction of metformin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in HbA1c decrease due to differences in metformin introduction timing (1st, 2nd, 3rd, 4th and later).
Key secondary outcomes
We compare the changes in body weight, biochemical examination, and incidence of adverse events at the time of introduction and at 24 weeks with the difference in the timing of Metformin introduction.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with type 2 diabetes who were newly prescribed metformin from January 1, 2008 to November 30, 2019 and can be followed by a 24-week observation period(January 1, 2008-May 20, 2020).
2)Patients who have not stopped/changed/added hypoglycemic agents other than metformin during the 24-week observation period(Regarding insulin, the number of units can be changed and canceled).
3)Patients who have not changed or discontinued other antidiabetic drugs at the timing of introducing metformin.
Key exclusion criteria
1)Patients with type 1 diabetes or secondary diabetes.
2)Patients whose other diabetes drugs are changed, increased, or discontinued at the same time as the start of metformin administration.
3) Patients who are changing diabetes drugs other than metformin (including changing the dose) during the 24-week observation period (changes in the number of insulin units can be incorporated).
4) Patients who are judged to have extremely poor medication compliance based on medical records.
5) Patients with steroid (oral/injection) treatment.
6) Patients with cancer (can be included if they are in follow-up during remission).
7) Patients who were hospitalized during the observation period.
8) Patients with severe infections and trauma.
9) Patients who are judged to be inappropriate as a subject by the doctor's judgment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
2320024
Address
4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL
0452615656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | MARINA |
| Middle name | |
| Last name | HARADA |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
2320024
Address
4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL
09053294853
Homepage URL
onyogora@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
Yokohama City University Public University Corporation Medical Research Ethics Committee for Humans
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
Tel
0453707627
rinri@yokohama-cu.ac.jp
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
横浜市立大学附属市民総合医療センター
浦舟金沢内科クリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze the factors that influence the effect of metformin
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046646
