UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015778 |
|---|---|
| Receipt number | R000018363 |
| Scientific Title | Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading. |
| Date of disclosure of the study information | 2014/11/28 |
| Last modified on | 2017/05/31 10:08:31 |
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Basic information
Public title
Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Acronym
Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Scientific Title
Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Scientific Title:Acronym
Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Region
| Japan |
Condition
Condition
Type 2 Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect and safety of tofogliflozin on glucose and lipid metabolism after test meal loading in male patient with type II diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in postprandial area under curve of serum triglycerides from baseline to 8week drug treatment to 8week discontinuation.
Key secondary outcomes
Change in the following items from baseline to 8week drug treatment to 8week discontinuation.
1) plasma sample
Glucose metabolism, lipid metabolism, electrolyte, hepatic function, atherosclerotic index.
2) urine sample
Glucose metabolism, electrolyte, renal function
3) Physical examination
Blood pressure, body weight, waist circumference, body mass index, PWV
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
Orally administration of 20 mg tofogliflozin once a day for 8 weeks, and 8 weeks discontinuation
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
Key inclusion criteria
The male patients with type II diabetes mellitus.
1) Age range from 20 to 74
2) Glycated hemoglobin less than 9.0 %
Key exclusion criteria
1) Patient who had SGLT2 inhibitor with past 2 months.
2) Patient whose concomitant drug had changed with past 2 months.
3) Patient who is diagnosed as contraindication of tofogliflozin.
(1) Patient with a history of hypersensitivity to any of the components of the product
(2) Patient with a severe ketotic diabetic coma or precoma.
(3) Patient with severe infectious disease, before and after operation, and a serious injury.
4) Patient receiving other diabetes drugs.
5) Patient with severe renal disorder (estimated GFR< 30mL/min/1.73m2).
6) Patient with a history of cerebral infarction.
7) Patient receiving diuretic drugs.
8) Patient whom the principle investigator or other investigator consider unsuitable.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Kobayashi |
Organization
Kanazawa Medical University
Division name
Department of General Internal Medicine
Zip code
Address
Daigaku 1-1 Uchinada Kahoku Ishikawa
TEL
076-218-8352
mary@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Kobayashi |
Organization
Kanazawa Medical University
Division name
Department of General Internal Medicine
Zip code
Address
Daigaku 1-1 Uchinada Kahoku Ishikawa
TEL
076-218-8352
Homepage URL
mary@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kowa Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kakuda Clinic
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
| 2014 | Year | 11 | Month | 28 | 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
| 2014 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018363
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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