UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015087 |
|---|---|
| Receipt number | R000017547 |
| Scientific Title | A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM) |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2017/03/27 17:31:34 |
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Basic information
Public title
A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
Acronym
A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
Scientific Title
A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
Scientific Title:Acronym
A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of SGLT2 inhibitors or DPP4 inhibitors on glycemic control and safty in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
SD of blood glucose by CGM
Key secondary outcomes
1)averate blood glucose, MAGE by CGM
2)FPG and PPG at 1, 2, 3, 4, 5, 6, 7 days of treatment
3)%chagne of FPG, HbA1c,IRI,CPR, a from baseline
4)a questionnaire survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitors:
This study to examine the change in SD of 24h and MAGE by CGM,blood glucose levels,Body weight,urine volume before and after the start.
Interventions/Control_2
DPP-4 inhibitors:
This study to examine the change in SD of 24h and MAGE by CGM,blood glucose levels,Body weight,urine volume before and after the start.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine and inpatient
2)HbA1c(NGSP):more than 7.0%, less than 14.0%
3)126mg/dl<=FPG<250mg/dl and 200mg/dl<=PPG<350mg/dl
4)eGFR more than 45ml/min/1.73m 2
5)Type 2 diabetes
6)Pts with written IC
7)Age more than 20, less than 85
Key exclusion criteria
1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)severe hepatic dysfunction
4)or severe renal dysfunction (Cr: more than 1.5mg/dl)
5)Patients who use of insulin
6)pregnacy
7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide
8)Patients judged by the investigator to be ineligible for some other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joe Nagakura |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
jo0806nagakura@hotmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
横浜市立大学附属市民総合医療センター（神奈川県）
横須賀市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/63/3/63_EJ15-0500/_article
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
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017547
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
