UMIN-CTR Clinical Trial

Basic information
Public title	Study for the effect on blood glucose fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor or to DPP-4 inhibitor/SGLT2 inhibitor combination tablet in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study -
Acronym	The effect on blood glucose fluctuation between DPP-4 inhibitor, SGLT2 inhibitor, and DPP-4 inhibitor/SGLT2 inhibitor combination in patients with type 2 diabetes.
Scientific Title	Study for the effect on blood glucose fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor or to DPP-4 inhibitor/SGLT2 inhibitor combination tablet in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study -
Scientific Title:Acronym	The effect on blood glucose fluctuation between DPP-4 inhibitor, SGLT2 inhibitor, and DPP-4 inhibitor/SGLT2 inhibitor combination in patients with type 2 diabetes.
Region	Japan

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

Objectives
Narrative objectives1	To assess the effects of switching teneligliptin to canagliflozin or to teneligliptin/ canagliflozin combination tablet on blood glucose fluctuation using continuous glucose monitoring system under meal tolerance test in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Mean amplitude of glycemic excursions during meal tolerance test
Key secondary outcomes	CGM measurements (M-value, SD, average daily risk range, AUC of blood glucose, MODD, average glucose level during meal tolerance test) Weight Blood pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
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	Switching from teneligliptin to canaglifozin
Interventions/Control_2	Switching from teneligliptin to teneligliptin/canagliflozin combination tablet
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) 20 to 80 years old 2) HbA1c 6.5-9.0% (NGSP) 3) Patients with type 2 diabetes who have been undergoing diet therapy and taking DPP-4 inhibitors for 3 month. Among DPP-4 inhibitors, teneligliptin has to be used for at least 1 week before the entry. 4) Written informed consent
Key exclusion criteria	1) hypersensitivity to canagliflozin or teneligliptin/ canagliflozin combination tablet. 2) uncontrolled diabetic retinopathy 3) severe liver dysfunction, renal dysfunction, or heart failure 4) pregnancy, nursing woman or possibly pregnant woman 5) severe diabetic ketosis, diabetic coma 6) severe infection, pre and post operation , severe trauma 7) uncontrolled diet therapy 8) deficiency of insulin secretion 9) BMI < 22kg/m2 10) eGFR < 45ml/min 11) patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	98

Research contact person
Last name of lead principal investigator	1st name Akinobu Middle name Last name Nakamura
Organization	Hokkaido University Hospital
Division name	Department of Medicine II
Zip code	060-8648
Address	N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL	011-706-5915
Email	akinbo@huhp.hokudai.ac.jp

Public contact
1st name of contact person	1st name Kyu Yong Middle name Last name Cho
Organization	Hokkaido University Hospital
Division name	Department of Medicine II/Clinical Research and Medical Innovation Center
Zip code	060-8648
Address	N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL	011-706-5915
Homepage URL
Email	kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hokkaido University Hospital Division of Clinical Research Administration
Address	n14w5, kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-7636
Email	crjimu@med.hokudai.ac.jp

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	北海道大学病院（北海道）、青木内科クリニック（北海道）、NTT東日本札幌病院（北海道）、JA北海道厚生連　帯広厚生病院（北海道）、日本赤十字社　釧路赤十字病院（北海道）、栗原内科（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、国家公務員共済組合連合会　斗南病院（北海道）、萬田記念病院（北海道）、横山内科クリニック（北海道）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 19 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	101
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	2017 Year 10 Month 19 Day
Date of IRB	2017 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2019 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033848