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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017006
Receipt No. R000019710
Scientific Title Effect on Insulin Resistance in Tofogliflozin-treated Japanese Type 2 diabetic patients
Date of disclosure of the study information 2015/04/01
Last modified on 2018/01/19

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Basic information
Public title Effect on Insulin Resistance in Tofogliflozin-treated Japanese Type 2 diabetic patients
Acronym Tofogliflozin and insulin sensitivity
Scientific Title Effect on Insulin Resistance in Tofogliflozin-treated Japanese Type 2 diabetic patients
Scientific Title:Acronym Tofogliflozin and insulin sensitivity
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of SGLT2 inhibitor(Tofogliflozin) on insulin sennsitivity in patients with type 2 diabetes treated with DPP4 inhibitor. Insulin resistance is measured by glucose clamp method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean change from baseline in GIR using glucose clamp technique.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tofogliflozin
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 (1)Diagnosed as Type 2 diabetes
(2)7=<HbA1c<10%
(3)18.5=<BMI<45
(4)20=<informed conscent age<75
(5)Registration inspection before 8 weeks or more, patients are administered without prescription change in the approved dosage regimen of diet and exercise therapy and DPP-4 inhibitors
(6)Subjects who give consent document about participation in the clinical study
Key exclusion criteria 1) Has hypersensitivity to tofogliflozin or any other excipient of tofogliflozin
2) With severe ketosis, diabetic coma, or precoma within 6 months
3) With severe infection, pre or post surgery, and serious trauma
4) With severe renal dysfunction
5) With severe liver dysfunction
6) Entered already with another clinical trials
(7) Considered as inadequate by the investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuro Matsuba
Organization Matsuba Medical Clinic
Division name Department of Diabetes & Endocrinology
Zip code
Address 2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL +810445221678
Email ikuro@matsuba-web.com

Public contact
Name of contact person
1st name
Middle name
Last name Ikuro Matsuba
Organization Matsuba Medical Clinic
Division name Department of Diabetes and Endocrinology
Zip code
Address 2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL +810445221678
Homepage URL
Email ikuro@matsuba-web.com

Sponsor
Institute Matsuba Medical Clinic
Institute
Department

Funding Source
Organization KOWA COMPANY,LTD
Organization
Division
Category of Funding Organization Profit organization
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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 17 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 11 Month 18 Day
Date trial data considered complete
2016 Year 11 Month 30 Day
Date analysis concluded
2017 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2018 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019710

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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