UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Title of the study (Brief title)	Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Region	Japan

Condition
Condition	Type 1 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of SGLT2 inhibitor Ipragliflozin for patients with type 1 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c levels
Key secondary outcomes	For 3 days of FGM, percentage of time of blood glucose level of less than 70mg/dl (hypoglycemia range) , percentage of time of blood glucose level of 180mg/dl or more (hyperglycemia range), percentage of time of blood glucose level 70-179mg/dl (normoglycemia range), percentage of time of blood glucose level less than 54mg/dl (severely hypoglycemic range), percentage of time of nocturnal hypoglycemia (0:00-5:59, less than 70 mg/dl), frequency of severe hypoglycemia (the extent of occurrence of coma, premature coma, convulsions need of third-person assistance, SD value, CV value, day difference variation, M value, MAGE, change in BMI, the change of insulin dose.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administered once a day Ipragliflozin 50mg after breakfast for three months or more
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.Applicable age 20 years old and under 75 years old 2.Patients diagnosed with type 1 diabetes for more than 1 year from the start of the study 3.Patients who underwent multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) 12 weeks before the start of the study 4.Patients with glycated hemoglobin (HbA1c) levels 7.0% or more and less than 10.5% 5.patient with body mass index (BMI) 20kg/m2 or more and 45.0kg/m2 or less
Key exclusion criteria	1.The patient with severe ketosis, diabetic comA or previous coma within six weeks before examination start 2.The patient who developed severe hypoglycemia (a diabetic coma or a previous coma and convulsionsneed the assistance of the third person) within six weeks before examination start 3.The patient with medically important renal disease such as a history of renal vascular occlusive disease, nephrectomy, kidney transplantations, etc 4.The patient with dysuria, anuria, oliguria or the symptom of the anuria 5.The patient whom urinary tract infection having subjective symptoms, a sexual organs infectious disease developed in within six weeks before examination start 6.The patient with a severe renal function disorder (eGFR <30mL/min/1.73m2 or serum creatinine level >= 2.0mg/dL) or the end-stage renal disease on dialysis 7.The patient with a proliferative retinopathy (however, patients symptoms are stable by implementing the photocoagulation, etc., can incorporate) 8.The patient complicated with serious digestive tract disturbance within two weeks before examination start or the patient who has an operation career of serious digestive tract disturbance 9.The patient with pregnancy or may be pregnant and the patient in nursing 10.The patient with severe infectious disease, serious injury and before and after operation 11.The patient who receives systemic administration of corticosteroids drugs 12.The patient with a serious liver function disorder more than 100 U/l of AST or ALT 13.The patient with a history of allergy to Ipragliflozin 14.The patient with the past of a malignant tumor or the malignant tumor at the moment 15.In addition, patients who test the attending physician has determined to be inappropriate as a subject
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Kawaguchi
Organization	Minami Osaka Hospital
Division name	Internal Medicine
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	0666850221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	Yuji Kawaguchi
Organization	Minami Osaka Hospital
Division name	Internal Medicine
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	0666850221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minami Osaka Hospital Internal Medicine
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Self funding
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	社会医療法人　景岳会　南大阪病院（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 02 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 15 Day
Last modified on	2019 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040503