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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022615
Receipt No. R000026065
Scientific Title Efficacy of ipragliflozin on diabetic nephropathy in patients with type 2 diabetes
Date of disclosure of the study information 2016/06/05
Last modified on 2018/02/05

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Basic information
Public title Efficacy of ipragliflozin on diabetic nephropathy in patients with type 2 diabetes
Acronym Efficacy of ipragliflozin on diabetic nephropathy in patients with type 2 diabetes
Scientific Title Efficacy of ipragliflozin on diabetic nephropathy in patients with type 2 diabetes
Scientific Title:Acronym Efficacy of ipragliflozin on diabetic nephropathy in patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes with/without 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 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, bodyweight, fasting plasma glucose, fasting serum lipids, abdominal adipose tissue, AST, ALT, and uric acid at week 24.

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 50 mg per day for 24 weeks
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. Type 2 diabetic patients
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 Division of Internal Medicine
Zip code
Address 1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL 0493-72-2333
Email itoven0214@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Ito
Organization Ogawa Red Cross Hospital
Division name Division of Internal Medicine
Zip code
Address 1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL 0493-72-2333
Homepage URL
Email itoven0214@yahoo.co.jp

Sponsor
Institute Ogawa Red Cross Hospital
Institute
Department

Funding Source
Organization Ogawa Red Cross Hospital
Organization
Division
Category of Funding Organization Other
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
2016 Year 06 Month 05 Day

Related information
URL releasing protocol
Publication of results 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
Anticipated trial start date
2014 Year 05 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
2016 Year 06 Month 05 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026065

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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