UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014306 |
|---|---|
| Receipt number | R000016658 |
| Scientific Title | Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control. |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2015/11/19 11:05:06 |
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Basic information
Public title
Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Acronym
Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Scientific Title
Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Scientific Title:Acronym
Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical study to determine the safest use of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control by diet therapy, exercise therapy, oral antidiabetic drugs, by InBody, which observes composition of the weight, and CGM, which observes glucose variability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Glycosylated hemoglobin (HbA1c) levels over 6 months.
Key secondary outcomes
1) Change in fasting blood glucose, body weight, waist circumference, IRI, serum lipid and body composition over 6 months.
2)CGM
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
Current treatment + Ipragliflozin
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
(1) HbA1c levels of >=6.5% to <8.5%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases
(2) Age >=20years on the date of submission of informed consent
(3) Under treatment with fixed diet and exercise therapy >=8weeks
(4) When treated with oral antidiabetic drugs; under treatment with a fixed dose and regimen >=8 weeks
(5) Submission of written informed consent for participation in this study
Key exclusion criteria
(1) Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions
(2) Application of contraindications contained in the package insert
(3) Severe renal function disorder
(4 )BMI is < 22kg/m2
(5) Under treatment with insulin,GLP-1 analog,or SGLT-2 inhibitor
(6) Pregnant women, women suspected of being pregnant, or lactating women
(7) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen clinic
Division name
Director
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Nakakinen clinic
Division name
Clinical Laboratory
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchii@kensei-kai.com
Sponsor or person
Institute
Nakakinen clinic
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
仲本内科クリニック(茨城県)、那珂記念MITOクリニック(茨城県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 18 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016658
