UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025454 |
|---|---|
| Receipt number | R000029291 |
| Scientific Title | The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes. |
| Date of disclosure of the study information | 2016/12/28 |
| Last modified on | 2020/07/14 18:59:06 |
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Basic information
Public title
The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Acronym
The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Scientific Title
The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Scientific Title:Acronym
The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of SGLT2 inhibitor tofogliflozin on glycemic daily valiation by blood glucose using CGMs(continuous glucose monitoring) in patient with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glycemic daily valiation in blood glucose using CGMs
Key secondary outcomes
The change in
1)fasting blood glucose
2)blood pressure
3)Safety evaluation
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
Tofogliflozin group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria
1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Cigarette smokers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282-87-2150
toshie@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Iijma |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282-87-2150
Homepage URL
toshie@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880kita-kobayashi,Mibu,Tochigi,Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
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
| 2016 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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 | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029291
