UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Ipragliflozin in type 1 diabetic patients
Acronym	Efficacy of Ipragliflozin in type 1 diabetic patients
Scientific Title	Efficacy of Ipragliflozin in type 1 diabetic patients
Scientific Title:Acronym	Efficacy of Ipragliflozin in type 1 diabetic patients
Region	Japan

Condition
Condition	type 1 diabetic patients
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of Ipragliflozin in type 1 diabetic patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	glycemic variability and treatment satisfaction
Key secondary outcomes

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	Out patients who receive therapy at our hospital Type 1 diabetic patients HbA1c: >= 7.0 and < 10% Patients who give written informed consent to participate in the study
Key exclusion criteria	Patients who had ketoacidosis or coma Malignancies or other diseases with poor prognosis eGFR<60mL/min/1.73m2
Target sample size	50

Research contact person
Name of lead principal investigator	1st name kazuya Middle name Last name murata
Organization	Ise Red Cross Hospital
Division name	Department of diabetes and metabolism
Zip code	516 8512
Address	1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL	0596-28-2171
Email	healthcheck@ise.jrc.or.jp

Public contact
Name of contact person	1st name satoshi Middle name Last name ida
Organization	Ise Red Cross Hospital
Division name	Department of diabetes and metabolism
Zip code	516-8512
Address	1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL	0596-28-2171
Homepage URL
Email	bboy98762006@yahoo.co.jp

Sponsor
Institute	Ise Red Cross Hospital Department of Metabolic Diseases
Institute
Department

Funding Source
Organization	Ise Red Cross Hospital Department of Metabolic Diseases
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Ise Red Cross Hospital
Address	1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
Tel	0596-28-2171
Email	jimubu@ise.jrc.or.jp

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	2019 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Enrolling by invitation
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 02 Month 28 Day
Last modified on	2020 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040689