UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the effect of blood glucose and metabolic risk factors by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes. -prospective observational study-
Title of the study (Brief title)	Switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the effectiveness of Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Frequency of hypoglycemia and glycemic control
Key secondary outcomes	Weight, BMI, Waist, Lipid metabolism, Blood pressure,Liver function, Complete blood count, renal function, electrolyte Dose and period of Sulfonylurea before clinical trial, Dose change of Sulfonylurea, Change of insulin dose (only patients using insulin)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with type 2 diabetes who have been taking Sulfonylurea, Glimepride(>=1 mg),Gliclazide (>=40 mg), Glibenclamide (>=1.25 mg) for more than 12 weeks, and are starting Ipragliflozine. 2)20 to 75 years old 3)BMI>=22 kg/m2 4)eGFR>=45 ml/min/1.73 m2 5)HbA1c 6.5 to 8.5 % 6)Written informed consent
Key exclusion criteria	1)Hypersensitivity to Ipragliflozine 2)Uncontrolled diabetic retinopathy 3)Severe liver dysfunction,renal dysfunction,or heart failure 4)Pregnancy,nursing woman or possibly pregnant woman 5)Severe diabetic ketosis,diabetic coma 6)Severe infection,pre and post operation,severe trauma 7)Deficiency of insulin secretion (fasting CPR <0.5 ng/ml) 8) Patients who are inadequate to enter this study due to uncontrolled diet therapy or the other reasons by physician's judgments
Target sample size	200

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
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	北海道大学病院（北海道）、小笠原クリニック札幌病院付属外来プラザ（北海道）、沖病院（北海道）、帯広厚生病院（北海道）、釧路赤十字病院（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、栗原内科（北海道）、高橋清仁クリニック（北海道）、苫小牧市立病院（北海道）、にわ糖尿病・内科クリニック（北海道）、北海道中央労災病院せき損センター（北海道）、萬田記念病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 26 Day
Anticipated trial start date	2015 Year 01 Month 30 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	Unpublished
URL releasing results
Results
Other related information	Assess the effectiveness of Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea

Management information
Registered date	2015 Year 01 Month 26 Day
Last modified on	2018 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018659