Unique ID issued by UMIN | UMIN000033902 |
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Receipt number | R000038639 |
Scientific Title | Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2020/05/27 10:53:50 |
Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study
EVOLB study
Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study
EVOLB study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare the effects of empagliflozin and omarigliptin on beta-cell function in patients with type 2 diabetes.
Safety,Efficacy
Comparing the two groups of change in beta-cell function (Insulin Secretion-Sensitivity Index-2; ISSI-2) over the 24-week treatment period.
Change in next items between baseline, 24 weeks of treatment, and 4 weeks of washout.
1. HbA1c
2. Glycated albumin
3. Fasting plasma glucose
4. Plasma glucose post 2h 75g-OGTT
5. Serum creatinine
6. eGFR based on serum creatinine
7. Urine albumin-creatinine ratio
8. Serum cystatin C
9. eGFR based on serum cystatin C
10. Triglyceride
11. HDL-cholesterol
12. LDL-cholesterol
13. Systolic blood pressure
14. Diastolic blood pressure
15. Pulse rate
16. Body weight
17. Waist circumference
18. Body composition
19. ISSI-2
20. delta-Ins0-120/delta-Glu0-120 x Matsuda index
21. Insulinogenic index
22. Matsuda index
23. HOMA2-IR
24. Fasting plasma glucagon
25. Plasma glucagon post 2h 75g-OGTT
26. Change in plasma glucagon during 2h 75g-OGTT
27. Medication compliance
28. Hypoglycemic events rates
29. Other adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Empagliflozin 10mg/day for 24 weeks
and washout for 4 weeks.
Omarigliptin 25mg/week for 24 weeks
and washout for 4 weeks.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1. Age between 20 and 85 years
2. Diabetes duration =<10 years
3. Both gender
4. Treated with diet +/- exercise therapy
5. Treated with oral hypoglycemic agents
6. Under stable diabetes treatment for over eight weeks
7. Fasting plasma glucose level between 70 mg/dL and 180 mg/dL
8. HbA1c =<10.0%
1. Use of insulin, DPP-4 inhibitor, GLP-1 receptor agonist, or SGLT-2 inhibitor
2. Type 1 diabetes or secondary forms of diabetes
3. Renal dysfunction (eGFR <35 ml/min/1.73m2) at screening
4. Hepatic dysfunction (AST and/or ALT >3x upper limit of normal)
5. Experiencing cardiovascular event within six month
6. Malignant neoplasm
7. Use of systemic steroid
8. Severe infection or injury
9. Hypersensitivity to empagliflozin or omarigliptin
10. Pregnant or willing to be pregnant during this study
11. Unable to obtain informed consent to this study
12. Unable to maintain compliance during this study
13. Expectation of extremely hyperglycemia during empagliflozin or omarigliptin washout period.
50
1st name | Tomoaki |
Middle name | |
Last name | Akiyama |
Yokohama City University Medical Center
Endocrinology and Diabetes
2320024
4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
045-261-5656
tomoakikunda@hotmail.com
1st name | Tomoaki |
Middle name | |
Last name | Akiyama |
Yokohama City University Medical Center
Endocrinology and Diabetes
232-0024
4-57 Urafune-cho Minami-ku Yokohama Kanagawa Japan
045-261-5656
tomoakikunda@hotmail.com
Yokohama City University Medical Center
Department of Endocrinology and Diabetes
Grant-in-Aid for Scientific Research
Japanese Governmental office
Japan
Yokohama City University Medical Ethics Committee for Humans
3-9 FukuuraKanazawa-ku, Yokohama, Kanagawa, Japan
+81-45-370-7627
rinri@yokohama-cu.ac.jp
NO
横浜市立大学附属市民総合医療センター(神奈川県)
2018 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 08 | Month | 27 | Day |
2018 | Year | 11 | Month | 20 | Day |
2018 | Year | 12 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2018 | Year | 08 | Month | 26 | Day |
2020 | Year | 05 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038639
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