UMIN-CTR Clinical Trial

Public title

A study on the efficacy and biogenic adaptability affected by ipragliflozin

Acronym

A study on the efficacy and biogenic adaptability affected by ipragliflozin

Scientific Title

A study on the efficacy and biogenic adaptability affected by ipragliflozin

Scientific Title:Acronym

A study on the efficacy and biogenic adaptability affected by ipragliflozin

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy of ipragliflozin in patient with poorly controlled type 2 diabetes undergoing conventional therapy. To investigate about the effects to appetite related hormone and diet behaviors multilaterally.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in HbA1c from 0 to 16 weeks

Key secondary outcomes

Percent change in HbA1c, and change and percent change following items during the investigational period

1) Fasting plasma glucose, serum insulin, glucagon, CRP, and GA
2) Body weight
3) Serum lipid (TC, LDL-C, TG, HDL-C)
4) Blood pressure
5) Appetite-related hormone (active ghrelin, and leptin)
6) Erythropoietin, reticulocyte
7) Appetite related visual analogue scale at fasting
8) Blood ketone bodies fraction
9) Urinary ketone, urinary sediment (bacteria, WBC)
10) Electrolyte in blood and spot urine, serum osmotic pressure, NT-proBNP, urinary creatinine, urinary glucose

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes
2) Aged from 20 to 75 years at providing consent
3) Poorly controlled patients who undergoes diet/ exercise therapy, hypoglycemic agents, insulin, or GLP-1 agonist therapy at least 12 weeks
4) HbA1c >=6.5% and <9.5%
5) BMI>=22 kg/m²
6) Provide written informed consent

Key exclusion criteria

1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma within 6 months
3) With severe infection, pre or post surgery, and serious trauma
4) With severe hepatic dysfunction
5) With renal dysfunction (Serum Creatinine male: >= 1.5 mg/dL, female: >= 1.3 mg/dL)
6) Is receiving steroids
7) Has history of gastrectomy (include segmentectomy and total resection, but not endoscopic mucosal resection)
8) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months at consent
9) Has history of receiving SGLT-2 inhibitor
10) Is pregnant, nursing, or planned to become pregnant
11) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
12) Considered as inadequate by the investigator

Target sample size

150

Name of lead principal investigator

1st name	Sakaguchi
Middle name
Last name	Kazuhiko

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology

Zip code

650-0017

Address

7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan

TEL

078-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp

Name of contact person

1st name	Sakaguchi
Middle name
Last name	Kazuhiko

Organization

Kobe University Graduate School of Medicine

Division name

Department of Internal Medicine

Zip code

650-0017

Address

7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan

TEL

078-382-6596

Homepage URL

Email

kzhkskgc@med.kobe-u.ac.jp

Institute

Kobe University

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB of Kobe University Hospital

Address

7-5-1, Kusunoiki-Cho, Chuoku, Kobe

Tel

078-382-6669

Email

chiken@med.kobe-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

01

Day

URL releasing protocol

none

Publication of results

Published

URL related to results and publications

none

Number of participants that the trial has enrolled

104

Results

After SGLT2 inhibitor adoministration, appetite of participants increased, and the level of plasma leptin levels increased.

Results date posted

2019

Year

12

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

type 2 diabetic patients, who were not administered SGLT2 inhibitor

Participant flow

Before and after SGLT2 inhibitor administration to 3 month, blood sample and appetite related questioning were done

Adverse events

none

Outcome measures

appetite
appetite related hormone

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

04

Month

13

Day

Date of IRB

2015

Year

04

Month

13

Day

Anticipated trial start date

2015

Year

04

Month

13

Day

Last follow-up date

2017

Year

11

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

10

Month

20

Day

Last modified on

2019

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017991