UMIN-CTR Clinical Trial

Basic information
Public title	Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Acronym	Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Scientific Title	Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Scientific Title:Acronym	Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes with diabetic nephropathy
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the long-term effects of ipragliflozin on the glycemic control, renal function and metabolic parameters in type 2 diabetic patients with diabetic nephropathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in HbA1c
Key secondary outcomes	Changes from baseline in urinary albumin-to-creatinine ratio (UACR), eGFR, blood pressure, body weight, fasting plasma glucose, fasting serum lipids, AST, ALT, and uric acid at week 104.

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 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 22 and lower than 45 kg/m2 4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and/or insulin therapy at baseline. 5. Patients who are able to provide written informed consent.
Key exclusion criteria	1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL. 5. Patients who have hepatic dysfunction.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Daisuke Ito
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Zip code
Address	1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL	0493-72-2333
Email	dito@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Daisuke Ito
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Zip code
Address	1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL	0493-72-2333
Homepage URL
Email	dito@saitama-med.ac.jp

Sponsor
Institute	Ogawa Red Cross Hospital
Institute
Department

Funding Source
Organization	Ogawa Red Cross Hospital
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	2018 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Date of IRB	2018 Year 03 Month 05 Day
Anticipated trial start date	2014 Year 05 Month 15 Day
Last follow-up date	2018 Year 05 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Ipragliflozin 50 mg per day for 24 weeks. After intervention therapy, patients returned to hospital based diabetes care according to their clinical needs.

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2020 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035545