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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015478
Receipt No. R000017991
Scientific Title A study on the efficacy and biogenic adaptability affected by ipragliflozin
Date of disclosure of the study information 2015/07/01
Last modified on 2019/12/09

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

Objectives
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

Assessment
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

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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
2015 Year 07 Month 01 Day

Related information
URL releasing protocol none
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2014 Year 10 Month 20 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017991

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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