UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026442 |
|---|---|
| Receipt number | R000030380 |
| Scientific Title | Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2017/03/07 16:12:26 |
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Basic information
Public title
Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Acronym
Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Scientific Title
Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Scientific Title:Acronym
Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of concomitant administration of DPP-4 and SGLT2 inhibitors on BMI, glycemic control, plasma lipids, and hepatic function in type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body mass index, HbA1c, plsma total cholesterol, HDL and LDL cholesterol, triglyceride, AST, ALT, and gamma-GTP levels at 6 months after the start of drug treatment
Key secondary outcomes
Plasma uric acid level at 6 months after the start of drug treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Administration of SGLT2 inhibitor (luseogliflozin 2.5 mg q.d., dapagliflozin 5 mg q.d., tofogliflozin 20 mg q.d., empagliflozin 10 mg q.d., or canagliflozin 100 mg q.d.) for 6 months
Interventions/Control_2
Concomitant administration of SGLT2 inhibitor and DPP-4 inhibitor (sitagliptin 50 mg q.d., vildagliptin 50 mg b.i.d., alogliptin 25 mg q.d., anagliptin 100 mg b.i.d., or linagliptin 5 mg q.d.) for 6 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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria
Having severe nephropathy.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
info@tonyo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
Homepage URL
info@tonyo.jp
Sponsor or person
Institute
Nagoya 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
Address
Tel
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
医療法人社団織田会あきしまクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 07 | 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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 04 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2017 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030380
