Unique ID issued by UMIN | UMIN000016539 |
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Receipt number | R000019197 |
Scientific Title | THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY) |
Date of disclosure of the study information | 2015/02/15 |
Last modified on | 2017/06/30 16:44:06 |
THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)
THe effect of canagliflozin on active GLP-1 levels and betatrophin (CANARIA STUDY)
THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)
THe effect of canagliflozin on active GLP-1 levels and betatrophin (CANARIA STUDY)
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
To investigate the effect of canagliflozin on glycemic control, serum active GLP-1,and betatrophin levels in patients with type 2 diabetes. Additional effect of teneligliptin also will be investigated.
Efficacy
Confirmatory
Pragmatic
Not applicable
Fasting plasma glucose, glucose after meal test, active plasma GLP-1 level, active serum betatrophin level
Plasma GIP level
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
3 days canagliflozin (100 mg 1x before breakfast) treatment with diet treatment
Thereafter addition of teneligliptin (20 mg 1x before breakfast) for 3 days
3 days diet treatment
Thereafter addition of teneligliptin (20 mg 1x before breakfast) for 3 days
20 | years-old | <= |
Not applicable |
Male and Female
1) patients (male or femal) aged 20 or over at enrollment
2) patients diagnosed as type 2 diabetes (based on criteria in Japan Diabetes Society 2010)
3)patients with diet and exercise therapy for diabetes during 12 weeks or over before enrollment (if patients have severe diabetic complication, diet therapy alone is applicable)
4)patients in whom type and dose of all anti-diabetic drugs was not changed during 4 weeks before starting study
5)patients who did not receive DPP4 inhibitors, GLP-1 receptor agonist, SGLT2 inhibitors during 1 month before starting study
6) patients with HbA1c more than or equal to 6.5% at enrollment
7)Patients who are hospitalized for glycemic control for type 2 diabetes
8)patients giving consent in writing for participation for this study
1)Patients with type 1 diabetes, pancreatic diabetes or secondary diabetes (Cushing syndrome, acromegaly etc.) diabetic coma or diabetic pre-coma, or type 1 diabetes
2)Patients who are not candidated for canagliflozin or teneligliptin treatment
3)Patients under insulin treatment
4)Heavy alcohol consumer (more than or equal to 60 g/day of pure alcohol )
5)Patients under pregnancy, possible pregnancy, or lactation
6)Patients with severe renal dysfunction (Cr >2.4 mg/dL or Ccr <30 mL/min)
7)Furthermore, patients judged as inadequacy for participation in this study by medical doctor
40
1st name | |
Middle name | |
Last name | Kohzo Takebayashi |
Dokkyo Medical University Koshigaya Hospital
Internal Medicine (Diabetes, Endocrinology, Hematology)
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
048-965-1111
takebaya@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Kohzo Takebayashi |
Dokkyo Medical University Koshigaya Hospital
Internal Medicine (Diabetes, Endocrinology, Hematology)
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
048-965-1111
takebaya@dokkyomed.ac.jp
Dokkyo Medical University Koshigaya Hospital
Mitsubishi Tanabe Pharma Corporation
Other
NO
獨協医科大学越谷病院(埼玉県)
2015 | Year | 02 | Month | 15 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 09 | Day |
2015 | Year | 02 | Month | 15 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2015 | Year | 02 | Month | 14 | Day |
2017 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019197
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