UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and Safety of Ipragliflozin, a selective SGLT2 inhibitor, in type 2 diabetes patients with insulin therapy
Acronym	Effect of Ipragliflozin on combination with insulin
Scientific Title	Efficacy and Safety of Ipragliflozin, a selective SGLT2 inhibitor, in type 2 diabetes patients with insulin therapy
Scientific Title:Acronym	Effect of Ipragliflozin on combination with insulin
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate the efficacy and safety of Ipragliflozin, a selective SGLT2 inhibitor, in type 2 diabetes patients with insulin therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c
Key secondary outcomes	fasting plasma glucose sCPR IRI LDLc HDLc TG urine protein urine keton body weight insulin dose hypoglycemia

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	Ipragliflozin
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Cases more than BMI22
Key exclusion criteria	Contraindiction for Ipragliflozin Patients who may have been pregnant or pregnant women Patients who are considered low-nutrition and dehydration
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Tamaru
Organization	Tokyo Medical University Hospital
Division name	Division of Diabetes,Metabolism and Endocrinology
Zip code
Address	6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL	03-3342-6111
Email	16000-all.tamaru@kpe.biglobe.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichi Tamaru
Organization	Tokyo Medical University Hospital
Division name	Division of Diabetes,Metabolism and Endocrinology
Zip code
Address	6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	16000-all.tamaru@kpe.biglobe.ne.jp

Sponsor
Institute	Tokyo Medical University Hospital Division of Diabetes,Metabolism and Endocrinology
Institute
Department

Funding Source
Organization	Tokyo Medical University Hospital Division of Diabetes,Metabolism and Endocrinology
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
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 09 Month 15 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	Preinitiation
Date of protocol fixation	2014 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2014 Year 09 Month 15 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 08 Month 27 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017422