UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)
Title of the study (Brief title)	THe effect of canagliflozin on active GLP-1 levels and betatrophin (CANARIA STUDY)
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Fasting plasma glucose, glucose after meal test, active plasma GLP-1 level, active serum betatrophin level
Key secondary outcomes	Plasma GIP level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	3 days canagliflozin (100 mg 1x before breakfast) treatment with diet treatment Thereafter addition of teneligliptin (20 mg 1x before breakfast) for 3 days
Interventions/Control_2	3 days diet treatment Thereafter addition of teneligliptin (20 mg 1x before breakfast) for 3 days
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	Not applicable
Gender	Male and Female
Key inclusion 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
Key exclusion 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
Target sample size	40

Research contact person
Name of lead principal investigator	Kohzo Takebayashi
Organization	Dokkyo Medical University Koshigaya Hospital
Division name	Internal Medicine (Diabetes, Endocrinology, Hematology)
Address	2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL	048-965-1111
Email	takebaya@dokkyomed.ac.jp

Public contact
Name of contact person	Kohzo Takebayashi
Organization	Dokkyo Medical University Koshigaya Hospital
Division name	Internal Medicine (Diabetes, Endocrinology, Hematology)
Address	2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL	048-965-1111
Homepage URL
Email	takebaya@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Koshigaya Hospital
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	獨協医科大学越谷病院(埼玉県)

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 15 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 14 Day
Last modified on	2017 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019197