UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026766 |
|---|---|
| Receipt number | R000030729 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2017/03/29 18:31:30 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Scientific Title:Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of exenatide versus sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin A1C levels, glycoalbumin levels, blood glucose/lipids levels, and flow-mediated vasodilation in forearm
Twelve weeks after administration
Key secondary outcomes
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria)
Twelve weeks after administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 exenatide first, then change to sitagliptin (for 12 weeks each)
Interventions/Control_2
Administration of sitagliptin first, then change to exenatide (for 12 weeks each)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diabetic patients whose HbA1c levels are greater than 7, despite medical therapy including life style change/medications for at least 8 weeks
2) 20 years of age or older and 75 years of age or younger.
3) Female or Male
4) Outpatients
5) Subjects who gave written informed consent
Key exclusion criteria
Allergy against exenatide /sitagliptin
2) Type I diabetes
3) Secondary diabetes
4) Poor-controlled diabetes (HbA1c>10.0 %)
5) Subjects who takes GLP-1 receptor agonist or DPP4 inhibitor.
6)History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
7) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
8) renal insufficiency: serum creatinine>1.3 (male)>1.2(female)
9) Symptomatic (NYHA III or IV) congestive heart failure
10) Malignancies or other diseases with poor prognosis
11) Pregnant
12) Subjects whose doctor in charge do not agree to join the trial
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Ezaki |
Organization
Tokorozawa Herat Center
Division name
Department of Cardiology
Zip code
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL
0429408611
hirotakaezaki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misa Ito |
Organization
Self-Defense Forces Fuji Hospital
Division name
Department of Internal Medicine
Zip code
Address
481-27 Subashiri, Oyamatyo, suntougun, Shizuoka, JAPAN 410-1431
TEL
0550-75-2311
Homepage URL
jumpimjumpim@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Self-Defense Forces Fuji Hospital
National defense medical college hospital
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
自衛隊富士病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 30 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030729
| 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 |
