UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021658 |
|---|---|
| Receipt number | R000024973 |
| Scientific Title | Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/11/13 12:47:17 |
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Basic information
Public title
Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Acronym
Comparison of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Scientific Title
Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Scientific Title:Acronym
Comparison of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety between two groups: one of which is initially administered an SGLT-2 inhibitor, luseogliflozin, followed by a DPP-4 inhibitor, sitagliptin, and the other which is initially administered a sitagliptin followed by luseogliflozin, in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in HbA1c
Key secondary outcomes
Blood glucose (fasting), IRI, CPR, Glucagon, Leptin, diponectin, TG, TC, LDL-C, HDL-C, ALT (GPT), AST (GOT), GGT, Uric acid, Creatinine, L-FABP, Urine microalbumin, Blood pressure, Body weight, Questionnaire (patient satisfaction, etc.)
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
After luseogliflozin 2.5 mg monotherapy for 3 months, sitagliptin 50 mg is concomitantly administered for 3 months
Interventions/Control_2
After sitagliptin 50 mg monotherapy for 3 months, luseogliflozin 2.5 mg is concomitantly administered 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
"1) Type 2 diabetes mellitus patients on diet and exercise therapy with inadequate blood glucose control
2) More than 20 years of age at the time of informed consent acquisition
3) Both females and males
4) Patients whose HbA1c (NGSP values) is more than 6.5%
5) Patients who received explanation of the study by using an informed consent form and gave written consent on study participation
"
Key exclusion criteria
"1) Patients with type 1 diabetes mellitus
2) Patients who had severe ketosis, diabetic coma, or precoma within 6 months
3) Patients with severe infection, perioperative patients, patients with severe trauma
4) Patients hypersensitive to ingredients of the drug used or its excipient
5) Patients with severe renal dysfunction (eGFR < 30 ml/min/1.73 m2) or terminal renal failure patients undergoing dialysis
6) Patients with severe hepatic dysfunction
7) Patients who are pregnant or breast-feeding
8) Patients considered inappropriate to participate in the study by the principal (sub-) investigator
"
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Takihata |
Organization
Miura Central Clinic
Division name
internal medicine
Zip code
Address
1738-1 Kamimiyada, Minamishitauramachi Miura, Kanagawa, Japan
TEL
046-888-5010
takihata-hki@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Takihata |
Organization
Miura Central Clinic
Division name
internal medicine
Zip code
Address
1738-1 Kamimiyada, Minamishitauramachi Miura, Kanagawa, Japan
TEL
046-888-5010
Homepage URL
takihata-hki@umin.ac.jp
Sponsor or person
Institute
Miura Central Clinic
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co. ,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | 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 | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024973
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
