UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038377 |
|---|---|
| Receipt number | R000043676 |
| Scientific Title | Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs? |
| Date of disclosure of the study information | 2019/10/26 |
| Last modified on | 2019/10/24 15:22:33 |
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Basic information
Public title
Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs?
Acronym
Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs?
Scientific Title
Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs?
Scientific Title:Acronym
Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs?
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, to obtain more effective glycemic control on combination therapy of these two anti-diabetic drugs in Japanese patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in HbA1c (after 6 months)
Key secondary outcomes
Hemoglobin, hematocrit, erythropoietin, AST, ALT, gamma GTP, Cre, eGFR, Na, K, Cl, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, RLP cholesterol, uric acid, BNP, cystatin C, CRP, hydroxybutyric acid, glucagon, KIM1, LFABP, 25(OD)VitD, leptin , IL-6, ApoB48, Treg, Th17, HMW adiponectin, FGF21, folic acid ,urinary glucose, urinary protein, urinary keton, urinary albumin, visceral fat area, BMI, blood-pressure, pulse, rate, DPP4 concentration and DPP4 activity.
(3 months and 6 months after treatment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
First, linagliptin 5mg is administered for 3 months. Then, add canagliflozin 100mg and administer 2 drugs in combination for 3 months.
Interventions/Control_2
First, canagliflozin 100mg is administered for 3 months. Then, add linagliptin 5mg and administer 2 drugs in combination for 3 months.
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)type 2 diabetes who have inadequate glycemic control (HbA1c more than 7%) under medical treatment by dieting and exercise cure and/or drug treatment
2)patients who have no history of cardiovascular disease
3)no treatment or treatment with stable doses of antihypertensive agents for at least 3 months prior to randomization.
4)no treatment or treatment with stable doses of antiplatelet agents for at least 3 months prior to randomization.
5)patients who give a written informed.
Key exclusion criteria
1)type 1 diabetes
2)patients with severe renal dysfunction (eGFR < 30 ml/min/1.73m2)
3)patients with liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
4)a pregnant woman and/or a woman under breast-feeding
5)patients who have diabetic proliferative retinopathy.
6)patients who have an anamnesis of hypersensitivity to the ingredient of a trial drugs.
7)patients who reciving GLP-1 recepter agonist.
8)patients who thought to be inappropriate to enter this study for some medical reasons by physician's judgments.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | YOSHIMASA |
| Middle name | |
| Last name | ASO |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu,Tocigi, 321-0293, Japan
TEL
0282-87-2150
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | TOSHIE |
| Middle name | |
| Last name | IIJIMA |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu,Tocigi, 321-0293, Japan
TEL
0282-87-2150
Homepage URL
toshie@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu,Tocigi, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 24 | Day |
Last modified on
| 2019 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043676
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