UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016539
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

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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 or person

Institute

Dokkyo Medical University Koshigaya Hospital

Institute

Department

Personal name



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

Value
https://center6.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