UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014638 |
|---|---|
| Receipt number | 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 14:13:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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)
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
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
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
K-Shimokawa@Yutenji-CL.Com
Sponsor or person
Institute
Association of medical corporation Toyukai, Yutenji Medical Clinic
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017030
