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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029628
Receipt No. R000033848
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 -
Date of disclosure of the study information 2017/10/19
Last modified on 2019/04/09

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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