UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of safety and efficacy of ipragliflozin in the treatment of diabetes in Kanagawa
Title of the study (Brief title)	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	Takehiro Kawata
Organization	IDOGAYA KENS Clinic
Division name	Medical director
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	Ikuro Matsuba
Organization	Matsuba Medical Clinic
Division name	Medical director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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