Unique ID issued by UMIN | UMIN000032705 |
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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 |
Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Effects of dapagliflozin and sitagliptin on endothelial fiction
Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Effects of dapagliflozin and sitagliptin on endothelial fiction
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
Comparison of dapagliflozin versus sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Efficacy
Hemoglobin A1C levels, glycoalbumin levels, blood glucose/lipids levels, and flow-mediated vasodilation in forearm
Twelve weeks after administration
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
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Administration of dapagliflozin first, then change to sitagliptin (for 12 weeks each)
Administration of dapagliflozin first, then change to exenatide (for 12 weeks each)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
33
1st name | Makoto |
Middle name | |
Last name | Ayaori |
Tokorozawa Heart Center
Shintokoekimae Clinic
359-1111
1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
0429291801
ayaori@ba2.so-net.ne.jp
1st name | Makoto |
Middle name | |
Last name | Ayaori |
Tokorozawa Heart Center
Shintokoekimae Clinic
359-1111
1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
0429291801
ayaori@ba2.so-net.ne.jp
Tokorozawa Heart Center
Foundation for Promotion of Defense Medicine
Non profit foundation
Tokorozawa Heart Center IRB
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
04-2940-8611
cs.thc@oukai.or.jp
NO
2018 | Year | 05 | Month | 24 | Day |
Unpublished
30
No longer recruiting
2018 | Year | 05 | Month | 16 | Day |
2018 | Year | 04 | Month | 19 | Day |
2018 | Year | 05 | Month | 24 | Day |
2021 | Year | 03 | Month | 31 | Day |
2018 | Year | 05 | Month | 24 | Day |
2020 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037294
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Research case data | |
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