UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029628 |
|---|---|
| Receipt number | 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 16:02:42 |
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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
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
kyuyong-cho@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033848
