UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040857 |
|---|---|
| Receipt number | 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 | 2022/11/28 18:16:39 |
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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
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
katou-knz@umin.ac.jp
Sponsor or person
Institute
Tonami general hospital
Department of diabetes mellitus and endocrinology
Institute
Department
Personal name
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
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
0
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
| 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
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046651
| Research Plan | |
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| Registered date | File name |
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