Unique ID issued by UMIN | UMIN000019462 |
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Receipt number | R000022504 |
Scientific Title | Investigation of factors which are related to urinary volume change after canagliflozin administration |
Date of disclosure of the study information | 2015/10/26 |
Last modified on | 2016/05/19 10:51:05 |
Investigation of factors which are related to urinary volume change after canagliflozin administration
Investigation of factors which are related to urinary volume change after canagliflozin administration
Investigation of factors which are related to urinary volume change after canagliflozin administration
Investigation of factors which are related to urinary volume change after canagliflozin administration
Japan |
Type2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Investigation of factors which are related to transient urinary volume change after canagliflozin administration, by evaluating endogenous hormones that are related to urinary volume change, in Japanese patients with type2 diabetes mellitus
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Urinary volume, the change of urinary volume, correlation between those parameters and factors which are related to urinary volume change
Blood glucose, the change of GLP-1 concentration, safety(adverse event, general clinical examination, electrocardiogram)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Canagliflozin 100mg, administration of once a day, for 6 days
25 | years-old | <= |
75 | years-old | > |
Male and Female
1. Age >= 25 years and < 75 years
2. Male and Female
3. Patients whose symptoms of type2 diabetes are stable.
4. If patients treated with one or two oral hypoglycemic agents, dose of them are stable over 3months.
5. BMI >=20kg/m2 and <=35kg/m2
6. HbA1c >= 7.0% and <= 10.0%
7. SBP >= 95mmHg and<= 160 mmHg, DBP >= 50 mmHg and <=100mmHg
8. Estimated glomerular filtration rate (eGFR)>=60 ml/min/1.73m2
9. Consent to study participation has been obtained in writing from the patient personally
1. Patients who have not received treatment of type 2 diabetes mellitus(diet therapy, exercise therapy, oral hypoglycemic agent and so on)
2. Patient with type 1 diabetes mellitus or with history of secondary diabetes mellitus
3. Patients who have experienced repeated severe hypoglycemic episodes
4. Patients with the history of serious diabetic complications requiring treatment
5. Patients treated with insulin, GLP-1 receptor agonist, SGLT-2 inhibitor, diuretic (including drug combination)
6. Patients with history of , or concurrent complication that affect renal function(renal disease, renal stone, prostatic inflammation and so on) , or patients with urinary-tract infection
7. Patients with history of drug or food allergies
8. Patients with history of myocardial infarction, congestive heart failure, unstable angina, cerebrovascular disease(except for lacunar infarction)within 6 months prior to screening visit (confirmation of eligibility)
9. Patients with history of TIA or cerebral infarction with clear neurological symptoms
10. Patients with peripheral arterial disease; Fontaine grade 3 or 4
11. Patients who correspond to contraindication or careful administration of canagliflozin (except for patient under treatment of hypoglycemic agents)
12. Patients with history of atrial fibrillation
13. Patients who are judged as inappropriate by investigators on screening examination.
12
1st name | |
Middle name | |
Last name | Kazuhiko Takano |
Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
The director of clinical pharmacology center
61-1, Shinei, Kiyota-ku, Sapporo-city, Hokkaido
011-882-0111
quintilesoutcome-com@umin.ac.jp
1st name | |
Middle name | |
Last name | Tetsuya Tsuji |
Quintiles Transnational Japan K.K.
Medical Affairs & Clinical Science
3-4-30 Miyahara, Yodogawa-ku, Osaka
080-4880-3819
quintilesoutcome-com@umin.ac.jp
Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Mitsubishi Tanabe Pharma Cooperation
Profit organization
Japan
NO
医療法人北武会 美しが丘病院(北海道) Medical Corporation Hokubukai Utsukushigaoka Hospital (Hokkaido)
2015 | Year | 10 | Month | 26 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 11 | Day |
2015 | Year | 10 | Month | 28 | Day |
2015 | Year | 12 | Month | 15 | Day |
2016 | Year | 01 | Month | 08 | Day |
2016 | Year | 01 | Month | 15 | Day |
2016 | Year | 02 | Month | 05 | Day |
2015 | Year | 10 | Month | 22 | Day |
2016 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022504
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