UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015478 |
|---|---|
| Receipt number | 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 17:38:38 |
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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
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
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017991
