UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031157
Receipt number R000035545
Scientific Title Long-term effects of ipragliflozin on diabetic nephropathy and blood pressure in patients with type 2 diabetes
Date of disclosure of the study information 2018/02/05
Last modified on 2020/02/11 13:58:31

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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 or person

Institute

Ogawa Red Cross Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035545


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name