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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014425
Receipt No. 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

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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
Email 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
Email ikuro@matsuba-web.com

Sponsor
Institute The Study Group of the Diabetes Committee, Kanagawa Physicians Association
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016787

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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