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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015055
Receipt No. R000017519
Scientific Title Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study.
Date of disclosure of the study information 2015/08/01
Last modified on 2015/08/03

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Basic information
Public title Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study.
Acronym Taking metformin before meal
Scientific Title Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study.
Scientific Title:Acronym Taking metformin before meal
Region
Japan

Condition
Condition diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Taking metformin with a meal has been shown to decrease its bioavailability. We hypothesized that taking metformin before a meal improves glucose metabolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postprandial glucose level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 taking metformin with a meal(1000mg)->wash out->taking metformin 30 minutes before meal(1000mg)
Interventions/Control_2 taking metformin 30 minutes before meal(1000mg)->wash out->taking metformin with a meal(1000mg)
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
25 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria We invited patients with type 2 diabetes who were being treated by metformin monotherapy and whose HbA1c was under 6.0% from Hospital of Kyoto Prefectural University of Medicine.
Key exclusion criteria Allergy to metformin
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 0752515506
Email sayarinapm@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Muhei Tanaka
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 0752515506
Homepage URL
Email muhei-t@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
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
Email

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
2015 Year 08 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 Completed
Date of protocol fixation
2014 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 04 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017519

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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