UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017006 |
|---|---|
| Receipt number | 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 12:02:35 |
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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
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
ikuro@matsuba-web.com
Sponsor or person
Institute
Matsuba Medical Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019710
