NIPH Clinical Trials Search

THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2015/02/15
Target sample size	40
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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

Outcome(s)

Primary Outcome	Fasting plasma glucose, glucose after meal test, active plasma GLP-1 level, active serum betatrophin level
Secondary Outcome	Plasma GIP level

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	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
Exclude criteria	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