UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009988 |
|---|---|
| Receipt number | R000011472 |
| Scientific Title | Effects of repaglinide and sitagliptin on daily glucose swing and endothelial function: an open-label parallel-group randomized trial |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2018/08/13 09:22:22 |
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Basic information
Public title
Effects of repaglinide and sitagliptin on daily glucose swing and endothelial function: an open-label parallel-group randomized trial
Acronym
R-GET
Scientific Title
Effects of repaglinide and sitagliptin on daily glucose swing and endothelial function: an open-label parallel-group randomized trial
Scientific Title:Acronym
R-GET
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of repaglinide and sitagliptin on daily glucose swing and endothelial function by an open-label parallel-group randomized manner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
continuous glucose monitor (CGM) marker, flow-mediated di;atation (FMD)
Key secondary outcomes
HbA1c, 1,5-AG, 8isoPGF2a, TBARS, total, LDL. HDL cholesterol triglyceride MDL and RLP cholesterol, AST ALT g-GTP LDH, BUN creatinine, cystatin C, urinary albumin excretion
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
repaglinide 24-48 h > sitagliptin 24-48 h > sitagliptin 12 week
Interventions/Control_2
sitagliptin 24-48 h > repaglinide 24-48 h > repaglinide 12 week
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
Type 2 diabetes mellitus and/or postprandial hyperglycemia
1. Not good glycemic control after diet and excise regimen and requires medical treatment
2. Aged 20 -79 years old
3. Males and females
4. HbA1c (NGSP) <9.0%
5. Provided written informed consent before any trial related activities commence
Key exclusion criteria
1. Hypoglycemia unawareness or recurrent major hypoglycaemia
2. Known severe liver disease
3. Known or suspected allergy to trial products or related products
4. Pregnant or planning to become pregnant within the next 12 months, breast-feeding
5. Any condition that the Investigator or Sponsor feel would interfere with trial participation or evaluation of results
6. Not provided written informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sata |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
14. 3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7859
mshimabukuro-ur@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardio-Diabetes Medicine
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7859
Homepage URL
mshimabukuro-ur@umin.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School of Health Biosciences
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School of Health Biosciences
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
徳島大学大学院 循環器内科（徳島）、医療法人 友愛会 豊見城中央病院 生活習慣病センター（沖縄）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011472
| Research Plan | |
|---|---|
| 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 |
