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Recruitment status Completed
Unique ID issued by UMIN UMIN000014638
Receipt No. R000017030
Scientific Title Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Date of disclosure of the study information 2014/07/24
Last modified on 2016/05/26

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Basic information
Public title Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Acronym Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Scientific Title Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Scientific Title:Acronym Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
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 50 mg ipragliflozin combination therapy in patients with poorly glycemic controlled type 2 diabetes nevertheless who undergo metformin treatment at least 12 weeks
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in HbA1c from baseline to 12 weeks
Key secondary outcomes Change or percent change in following items from baseline to 12 weeks

1) Body weight
2) Waist circumference
3) Serum lipids
4) Blood pressure
5) Fasting plasma glucose
6) Adiponectin
7) Measurement of body composition using body composition analyzer (MC-780A, Manufactured by TANITA)

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 12 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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 20 to 75 years at providing consent
2) Poorly glycemic controlled patients with HbA1c over 7.0% at least 2 points within 12 weeks before initiation, nevertheless who undergoes metformin treatment over 12 weeks
3) HbA1c >= 7.0%
4) BMI >= 25 kg/m2
5) Received informed consent
Key exclusion criteria 1) Type 1 diabetes
2) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
3) With severe ketosis, diabetic coma, or precoma
4) With severe infection, pre or post surgery, and serious trauma
5) Has history of lactic acidosis
6) With severe hepatic disorder
7) With gastrointestinal disorder such as diarrhea or vomiting, concerning dehydration or dehydration status
8) Moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL)
9) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months
10) Is receiving SGLT-2 inhibitor, insulin therapy at initiation
11) Is pregnant, nursing, or planned to become pregnant
12) Considered as inadequate by the investigator
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Shimokawa
Organization Association of medical corporation Toyukai, Yutenji Medical Clinic
Division name Medical director
Zip code
Address 1-13-12 Gohongi, Meguro-ku, Tokyo, Japan
TEL 03-5724-5222
Email K-Shimokawa@Yutenji-CL.Com

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Shimokawa
Organization Association of medical corporation Toyukai, Yutenji Medical Clinic
Division name Medical director
Zip code
Address 1-13-12 Gohongi, Meguro-ku, Tokyo, Japan
TEL 03-5724-5222
Homepage URL
Email K-Shimokawa@Yutenji-CL.Com

Sponsor
Institute Association of medical corporation Toyukai, Yutenji Medical 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 07 Month 24 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 07 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 25 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 07 Month 24 Day
Last modified on
2016 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017030


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