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Recruitment status Completed
Unique ID issued by UMIN UMIN000015104
Receipt No. R000017580
Scientific Title Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Date of disclosure of the study information 2014/09/10
Last modified on 2017/12/25

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Basic information
Public title Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Acronym Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Scientific Title Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Scientific Title:Acronym Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
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 and safety of ipragliflozin under clinical use condition, and investigate suitable patients who can be administrated ipragliflozin using stratified analysis by BMI before administration and duration of disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change and percent change in HbA1c from baseline to 52 weeks
Key secondary outcomes Change and percent change in following items from baseline to 12, 24, and 52 weeks
1) HbA1c (Except for the change at 52 week)
2) fasting plasma glucose, insulin, HOMA-beta, HOMA-R
3) body weight and waist circumference
4) Serum lipid (TC, LDL-C, TG, HLD-C)
5) Blood pressure

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 for 52 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged from 20 to 80 years at providing consent
2) With poorly controlled patients who undergoes diet/exercise therapy or hypoglycemic agent at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 20kg/m2
5) 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 moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL)
5) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months
6) Is receiving SGLT-2 inhibitor at initiation
7) Is nursing or pregnant or planned to become pregnant
8) Has hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
9) Considered as inadequate by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Seino
Organization Seino Naika Clinic
Division name Medical director
Zip code
Address 6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL 024-983-1024
Email kn7jh5@bma.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Seino
Organization Seino Naika Clinic
Division name Medical director
Zip code
Address 6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL 024-983-1024
Homepage URL
Email kn7jh5@bma.biglobe.ne.jp

Sponsor
Institute Seino Naika Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
2014 Year 09 Month 10 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 09 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 17 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
2014 Year 09 Month 10 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017580


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