UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032705 |
|---|---|
| Receipt number | R000037294 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients |
| Date of disclosure of the study information | 2018/05/24 |
| Last modified on | 2020/05/25 17:57:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Acronym
Effects of dapagliflozin and sitagliptin on endothelial fiction
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Scientific Title:Acronym
Effects of dapagliflozin and sitagliptin on endothelial fiction
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of dapagliflozin 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 -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
Administration of dapagliflozin first, then change to sitagliptin (for 12 weeks each)
Interventions/Control_2
Administration of dapagliflozin 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
| 80 | 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
1) Allergy against dapagliflozin/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 | Makoto |
| Middle name | |
| Last name | Ayaori |
Organization
Tokorozawa Heart Center
Division name
Shintokoekimae Clinic
Zip code
359-1111
Address
1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
TEL
0429291801
ayaori@ba2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ayaori |
Organization
Tokorozawa Heart Center
Division name
Shintokoekimae Clinic
Zip code
359-1111
Address
1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
TEL
0429291801
Homepage URL
ayaori@ba2.so-net.ne.jp
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokorozawa Heart Center IRB
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel
04-2940-8611
cs.thc@oukai.or.jp
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
| 2018 | Year | 05 | Month | 24 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
