UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014425 |
|---|---|
| Receipt number | R000016787 |
| Scientific Title | A study of safety and efficacy of ipragliflozin in the treatment of diabetes in Kanagawa |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2018/11/21 16:45:01 |
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Basic information
Public title
A study of safety and efficacy of ipragliflozin in the treatment of diabetes in Kanagawa
Acronym
ASSIGN-K
Scientific Title
A study of safety and efficacy of ipragliflozin in the treatment of diabetes in Kanagawa
Scientific Title:Acronym
ASSIGN-K
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide the evidences for appropriately clinical using of SGLT-2 inhibitors in terms of the efficacy and safety under clinical use condition of ipragliflozin monotherapy, switching from existing hypoglycemic agent, and combination therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 52 weeks
Key secondary outcomes
Change in following items from baseline to 4, 12, 24, 36 and 52 weeks
For patients receiving ipragliflozin after 52 weeks, change in following items and HbA1c from baseline to 78 and 104 weeks are also evaluated.
1) Change in fasting and postprandial glucose from baseline
2) Change in body composition from baseline
3) Change in body weight and waist circumference from baseline
4) Change in serum lipids, free fatty acid, and blood pressure from baseline
5) Improvement from baseline of HbA1c by patient characteristic at initiation
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
Oral administration of 50 mg ipragliflozin once a day, pre or post breakfast for 52 weeks. The dose can be increased up to 100 mg if the effect is insufficient.
Patients who satisfy the inclusion and exclusion criteria for extension administration at 52 weeks and who are considered there are not any problems with safety of extension administration of ipragliflozin by investigator can continue the study treatment until 104 weeks if the written informed consent for extension study is provided.
If patients have severe hepatic dysfunction, it is possible to start from low dose according to the condition.
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) 20 years and older at providing consent
2) Outpatients providing written informed consent
3) Male and Female
4) Initiating administration of ipragliflozin because of poorly controlled glucose level whereas undergoing diet/exercise therapy or additional hypoglycemic agent at least 12 weeks
5) HbA1c >= 6.0 %
[Inclusion criteria for extension administration]
Patients who satisfy 1)-5) and both of following conditions
6) Patients considered the extension treatment with ipragliflozin is required by investigator
7) Patients who agreed with extension treatment with ipragliflozin
Key exclusion criteria
1) Has hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
2) With severe ketosis, diabetic coma, or precoma within 6 months
3) With severe infection, pre or post surgery, and serious trauma
4) With severe renal dysfunction
5) Considered as inadequate by the investigator
6) Is pregnant or possibility of pregnant, planning or possibility of pregnant during research (Except for acceptable method of birth control, surgically sterilized, and postmenopause), or nursing
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Kawata |
Organization
IDOGAYA KENS Clinic
Division name
Medical director
Zip code
Address
2nd Koyo Building 3F, 213, Idogaya-shimomachi, South Ward, Yokohama City, Kanagawa, Japan
TEL
045-721-1024
t2kawata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuro Matsuba |
Organization
Matsuba Medical Clinic
Division name
Medical director
Zip code
Address
2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL
044-522-1678
Homepage URL
ikuro@matsuba-web.com
Sponsor or person
Institute
The Study Group of the Diabetes Committee, Kanagawa Physicians Association
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 | 30 | 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
1. Ipragliflozin Improves Glycemic Control and Decreases Body Fat in Patients With Type 2 Diabetes Mellitus. Kawata T, et al. J Clin Med Res. 2017 Jul; 9(7): 586-595.
2. Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study. Iizuka T, et al. J Clin Med Res. 2016 Feb; 8(2): 116-125.
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 | 07 | 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
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016787
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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