UMIN-CTR Clinical Trial

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
Email	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
Email	onyogora@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046646