UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016539
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)
Acronym THe effect of canagliflozin on active GLP-1 levels and betatrophin (CANARIA STUDY)
Scientific Title THe effect of canagliflozin on active GLP-1 levels and betatrophin in patients with type 2 diabetes (CANARIA-STUDY)
Scientific Title:Acronym 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
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
Address 2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL 048-965-1111
Email takebaya@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.