| 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 |
Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
| Japan |
Type 2 diabetes
| Endocrinology and Metabolism |
Others
NO
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
Safety,Efficacy
Change in HbA1c from baseline to 12 weeks
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
| Medicine |
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
| 20 | years-old | <= |
| 75 | years-old | >= |
Male and Female
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
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
35
| 1st name | |
| Middle name | |
| Last name | Kotaro Shimokawa |
Association of medical corporation Toyukai, Yutenji Medical Clinic
Medical director
1-13-12 Gohongi, Meguro-ku, Tokyo, Japan
03-5724-5222
K-Shimokawa@Yutenji-CL.Com
| 1st name | |
| Middle name | |
| Last name | Kotaro Shimokawa |
Association of medical corporation Toyukai, Yutenji Medical Clinic
Medical director
1-13-12 Gohongi, Meguro-ku, Tokyo, Japan
03-5724-5222
K-Shimokawa@Yutenji-CL.Com
Association of medical corporation Toyukai, Yutenji Medical Clinic
Astellas Pharma Inc.
Profit organization
NO
| 2014 | Year | 07 | Month | 24 | Day |
Partially published
Completed
| 2014 | Year | 07 | Month | 11 | Day |
| 2014 | Year | 07 | Month | 25 | Day |
| 2014 | Year | 07 | Month | 24 | Day |
| 2016 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017030