UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014195 |
|---|---|
| Receipt number | R000016529 |
| Scientific Title | Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2016/07/06 13:51:04 |
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Basic information
Public title
Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Acronym
Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Scientific Title
Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Scientific Title:Acronym
Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety under clinical use condition of ipragliflozin. To investigate the influences of dietry composition (intake of carbohydrate and lipid) to the efficacy and safety, and the change of palatability (appetite, incentive to sugar, degree of acquisition desire).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 24 weeks
Key secondary outcomes
1) Change and percent change in following
items from baseline to 4 week, 12 week,
and 24 week
fasting plasma glucose
HbA1c (Except for the change at 24 week)
Body weight
2) Stratification analysis on efficacy of
ipragliflozin
Dietary composition with BDHQ (intake of
carbohydrate and lipid)
3) Palatability change of diet (appetite,
incentive to sugar, degree of acquisition
desire)
Comparison of ipragliflozin treated group with other medicated group
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 50mg ipragliflozin once a day, pre or post breakfast for 24 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese patient who meets all the following inclusion criteria
1) Type 2 diabetes patients with untreated or treated with hypoglycemic agent
2) 20 years and older
3) BMI >= 22kg/m2
4) HbA1c >= 6.5%
5) Received written informed consent
Key exclusion criteria
1) With severe ketosis, history of diabetic or precoma, severe infection, pre or post surgery, and severe trauma, hypersensitivity to ipragliflozin or any other excipient of ipragriflozin
2) With hypophyseal dysfunction or adrenal insufficiency who have high possibility of induces hypoglycemia
3) With urinary tract or genital infection
4) With severe hepatic dysfunction
5) Is receiving SGLT-2 inhibitors at initiation of this study
6) Is nursing or pregnant or planned to become pregnant
7) Considered as inadequate by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kanno |
Organization
Association of medical corporation Ouitsu-kai, Kanno Clinic
Division name
Medical director
Zip code
Address
3-44-17, Shimorenjaku, Mitaka-city, Tokyo
TEL
0422-40-5022
kzkanno@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kanno |
Organization
Association of medical corporation Ouitsu-kai, Kanno-naika
Division name
Medical director
Zip code
Address
3-44-17, Shimorenjaku, Mitaka-city, Tokyo
TEL
0422-40-5022
Homepage URL
kzkanno@gmail.com
Sponsor or person
Institute
Association of medical corporation Ouitsu-kai, Kanno-naika
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
| 2014 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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 | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 07 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016529
