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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014388
Receipt No. 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

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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
Email 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
Email katom@gol.com

Sponsor
Institute Kato clinic of Internal medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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