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Recruitment status Completed
Unique ID issued by UMIN UMIN000014306
Receipt No. R000016658
Official scientific title of the study Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Date of disclosure of the study information 2014/06/18
Last modified on 2015/11/19

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Basic information
Official scientific title of the study Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Title of the study (Brief title) Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Region
Japan

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

Objectives
Narrative objectives1 Clinical study to determine the safest use of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control by diet therapy, exercise therapy, oral antidiabetic drugs, by InBody, which observes composition of the weight, and CGM, which observes glucose variability.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in Glycosylated hemoglobin (HbA1c) levels over 6 months.
Key secondary outcomes 1) Change in fasting blood glucose, body weight, waist circumference, IRI, serum lipid and body composition over 6 months.
2)CGM

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 Current treatment + Ipragliflozin
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) HbA1c levels of >=6.5% to <8.5%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases
(2) Age >=20years on the date of submission of informed consent
(3) Under treatment with fixed diet and exercise therapy >=8weeks
(4) When treated with oral antidiabetic drugs; under treatment with a fixed dose and regimen >=8 weeks
(5) Submission of written informed consent for participation in this study
Key exclusion criteria (1) Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions
(2) Application of contraindications contained in the package insert
(3) Severe renal function disorder
(4 )BMI is < 22kg/m2
(5) Under treatment with insulin,GLP-1 analog,or SGLT-2 inhibitor
(6) Pregnant women, women suspected of being pregnant, or lactating women
(7) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size 100

Research contact person
Name of lead principal investigator Takeshi Osonoi
Organization Nakakinen clinic
Division name Director
Address 745-5, Nakadai, Naka, Ibaraki
TEL 029-353-2800
Email t-osonoi@kensei-kai.com

Public contact
Name of contact person Kensuke Ofuchi
Organization Nakakinen clinic
Division name Clinical Laboratory
Address 745-5, Nakadai, Naka, Ibaraki
TEL 029-353-2800
Homepage URL
Email k-ofuchii@kensei-kai.com

Sponsor
Institute Nakakinen 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)

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 仲本内科クリニック(茨城県)、那珂記念MITOクリニック(茨城県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 18 Day

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 01 Day
Anticipated trial start date
2014 Year 06 Month 27 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 11 Month 10 Day
Date analysis concluded
2015 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2015 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016658


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