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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040857
Receipt No. R000046651
Scientific Title Efficacy of metformin 1000mg once or twice daily in patients with type 2 diabetes
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/22

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Basic information
Public title Efficacy of metformin 1000mg once or twice daily in patients with type 2 diabetes
Acronym Efficacy of metformin 1000 mg once or twice daily
Scientific Title Efficacy of metformin 1000mg once or twice daily in patients with type 2 diabetes
Scientific Title:Acronym Efficacy of metformin 1000 mg once or twice daily
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 the difference in efficacy depending on the administration method of metformin 1000 mg/day.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 24-hour average blood glucose, fasting blood glucose, SD and CV.
Key secondary outcomes TIR(time in range), TAR(time above range), TBR(time below range), MAGE(mean amplitude of glucose excursion), maximum blood glucose level, minimum blood glucose level and safety.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We evaluate glycemic dynamics for 14 days with flash glucose monitoring (FGM) in patients with type 2 diabetes receiving 1000 mg/day of metformin.
First half of observation period (Day 1-7): Metformin 1000 mg orally twice daily (after morning and dinner).
Late observation period (Day 8-14): Metformin 1000 mg orally once daily (after breakfast).
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes
Administration of metformin 1000 mg/day
eGFR 45ml/min/1.73m2<=
Key exclusion criteria 1. Patients with a history of hypersensitivity to metformin components or biguanide drugs
2. Patients with a history of lactic acidosis
3. Patients with severe renal dysfunction or dialysis patients
4. Patients with severe liver dysfunction
5. Patients with severely impaired cardiovascular system or pulmonary function and other patients who are prone to hypoxemia
6. Patients with dehydration or suspected dehydration
7. Excessive alcohol drinkers
8. Patients with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
9. Patients with severe infection, before and after surgery, and serious trauma
10. Patients with malnutrition, starvation, weakness, pituitary dysfunction, or adrenal insufficiency
11. Pregnant women, women who may be pregnant, or women who are breast-feeding
12.Other cases judged by the investigator to be inappropriate for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Hayakawa
Organization Tonami general hospital
Division name Department of diabetes mellitus and endocrinology
Zip code 939-1395
Address 1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL 0763-32-3320
Email thayakawa-endo@umin.ac.jp

Public contact
Name of contact person
1st name Ken-ichiro
Middle name
Last name Kato
Organization Tonami general hospital
Division name Department of diabetes mellitus and endocrinology
Zip code 939-1395
Address 1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL 0763-32-3320
Homepage URL
Email katou-knz@umin.ac.jp

Sponsor
Institute Tonami general hospital
Department of diabetes mellitus and endocrinology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tonami general hospital Ethics Committee
Address 1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
Tel 0763-32-3320
Email thayakawa-endo@umin.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

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 06 Month 16 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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=R000046651

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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