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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009988
Receipt No. 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

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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
Email 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
Email mshimabukuro-ur@umin.ac.jp

Sponsor
Institute The University of Tokushima Graduate School of Health Biosciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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