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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022794
Receipt No. R000026272
Scientific Title Defining a novel law of glucose homeostasis under Dapagliflozin usage by mathematical model approach
Date of disclosure of the study information 2016/08/31
Last modified on 2017/08/15

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Basic information
Public title Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach
Acronym Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach
Scientific Title Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach
Scientific Title:Acronym Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Finding a new blood glucose homeostasis law using 100 person's time series data ,which were obtained during OGTT or Hyperinsulinemic euglycemic clamp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Finding a new blood glucose homeostasis law
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 One hundred person's time series boold glucose value or hormons concentration data, which were obtained immediately after taking SGLT2 inhibitor.
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 mellitus who has not been administered SGLT2 inhibitors
2) 20-75 years old,
3) having a will to attend this study
Key exclusion criteria 1) pregnant or breast-feeding women
2) insulin antibody positive (>10 arbitrary unit)
3) having allergy or skin trouble for oral hypoglycemic agants or insulin
4) type 1 diabetes or other specific type of diabetes
5) severe liver dysfunction (transaminase twice over the normal limit)
6) severe renal dysfunction (eGFR < 50)
7) severe heart failure (NYHA>2)
8) long-acting insulin, long-acting GLP-1 RA, or long-acting DPP-4 inhibitor user
9) psychological disorder
10) recent severe hypoglycemia or hypoglycemia unawareness
11) contraindication of dapagliflozine
11) others inappropriate for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-76-382-5861
Email kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-76-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization AstraDeneca, Ono pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization Other
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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 31 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
2016 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 08 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
2016 Year 06 Month 20 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026272

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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