UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014388 |
|---|---|
| Receipt number | R000016747 |
| Scientific Title | A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose |
| Date of disclosure of the study information | 2014/06/26 |
| Last modified on | 2015/07/01 16:23:11 |
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Basic information
Public title
A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose
Acronym
A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose
Scientific Title
A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose
Scientific Title:Acronym
A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose
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 change of blood glucose and urine glucose level using by CGM and SUMG (Ucheck manufactured by TANITA) under clinical use condition at pre and post ipragliflozin monotherapy or combination therapy in patients with poorly controlled type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 12 weeks
Key secondary outcomes
Change and percent change in following items from baseline to 12 weeks
1) AUC of blood glucose 160 mg/dL or less by CGM
2) AUC of urinary glucose by SMUG
3) 2-hour postprandial blood glucose and urinary glucose levels
4) Body composition (body fat, and body water)
5) Glycoalbumin (GA)
6) Body weight
7) Waist circumference
8) Serum lipids
9) Blood pressure
10) Other information such as diet record, include DTR-QOL
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 50 mg ipragliflozin once a day, pre or post breakfast for 12 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged from 20 to 70 years at providing consent
2) Poorly controlled patients who undergoes diet/exercise therapy or hypoglycemic agent at least 6 weeks
3) HbA1c >= 7.0%
4) BMI >= 22.0 kg/m2
5) Provide written informed consent
Key exclusion criteria
1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With moderate or severe renal dysfunction (Serum Creatinin male: >= 1.5 mg/dL, female: >= 1.3 mg/dL)
5) Is receiving SGLT-2 inhibitor, insulin at initiation
6) Is nursing or pregnant or planned to become pregnant
7) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragriflozin
8) Considered as inadequate by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutoshi Kato |
Organization
Kato clinic of Internal medicine
Division name
Medical director
Zip code
Address
#201 Station heights Takasago, 3-11-14 Takasago, Katsushika-ku, Tokyo, Japan
TEL
03-5668-2161
katom@gol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutoshi Kato |
Organization
Kato clinic of Internal medicine
Division name
Medical director
Zip code
Address
#201 Station heights Takasago, 3-11-14 Takasago, Katsushika-ku, Tokyo, Japan
TEL
03-5668-2161
Homepage URL
katom@gol.com
Sponsor or person
Institute
Kato clinic of Internal medicine
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 | 26 | 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
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 27 | 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
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016747
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