UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031686 |
|---|---|
| Receipt number | R000036188 |
| Scientific Title | The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect. |
| Date of disclosure of the study information | 2018/03/16 |
| Last modified on | 2019/06/13 21:45:36 |
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Basic information
Public title
The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect.
Acronym
The effect of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance
Scientific Title
The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect.
Scientific Title:Acronym
The effect of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, a single effect and chronic effect.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, a single effect and chronic effect.
Key secondary outcomes
After administration of Tofogliflozin
-Intrahepatic lipid
-Intramyocellular lipid
-Visceral fat area
-Subcutaneous fat area
-Body weight, Body composition
-Endogenous glucose production
-Insulin sensitivity
-Metabolic flexibility
-Metabolome analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
take Tofogliflozin orally
One day and 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
-type 2 diabetes mellitus men
-BMI range: 18.5-30 kg/m2
-HbA1c range:7.5-10.0%
-The patient who did not being changed the way to take diabetes medicines(additional dosage, discontinulation of administration or changing dosage) within 12 weeks before agreement acquisition
-Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding
Key exclusion criteria
-type 1 diabetes mellitus
-past history of taking Tofogliflozin
-BMI range:>30 or <18.5 kg/m2
-liver dysfunction(AST,ALT => 51U/L,gamma-GTP over 101U/L)
-renal dysfunction or eGFR level =< 60mL/min/1.73m2
-Patient with severe heart diseases (for example, heart failure and unstable angina) or the patient who occured myocardial infarction and anginal attack after 24 weeks ago from observation period
-patient who had an apoplexy spasm (cerebral infarction and cerebral hemorrhage) within 24 weeks until agreement acquisition
-patient with malignant tumor
-patient with advanced diabetes complications (neuropathy , retinopathy and nephropathy)
-patient of serious illness ketotic, a diabetic coma or the previous coma
-Patient with the endocrine diseases for which treatment is insufficient for hormone replenishment method of treatment (for example,pituitary disease, thyroid disease and adrenal disease)
-anemia beyond the degree of middle class (hemoglobin < 9.5g/dL)
-drunkard(for example 1 daily mean sake, by 3 gou and beer, more than 3 flagons)
-subjects judged unsuitable to the study from staff
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tamura |
Organization
University of Juntendo
Division name
Department of Endocrinology & Metabolism,Sportology center, Faculty of International Liberal Arts. Area of Global Health service
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 JAPAN
TEL
03-3837-0618
hkaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyoshi Kaga |
Organization
University of Juntendo
Division name
Department of Endocrinology and Metabolism, Sportology Center
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 JAPAN
TEL
03-3887-0618
Homepage URL
hkaga@juntendo.ac.jp
Sponsor or person
Institute
University of Juntendo
Institute
Department
Personal name
Funding Source
Organization
University of Juntendo
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 03 | Month | 16 | 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
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036188
