UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Title of the study (Brief title)	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	Kotaro Shimokawa
Organization	Association of medical corporation Toyukai, Yutenji Medical Clinic
Division name	Medical director
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	Kotaro Shimokawa
Organization	Association of medical corporation Toyukai, Yutenji Medical Clinic
Division name	Medical director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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