Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study

Effects of empagliflozin vs omarigliptin on beta-cell function in patients with type 2 diabetes: an open-label randomized controlled study - EVOLB study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033902

Enrollment

Registered

2018-12-01

Start date

2018-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Empagliflozin 10mg/day for 24 weeks and washout for 4 weeks. Omarigliptin 25mg/week for 24 weeks and washout for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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%

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Comparing the two groups of change in beta-cell function (Insulin Secretion-Sensitivity Index-2; ISSI-2) over the 24-week treatment period.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTomoaki Akiyama

Yokohama City University Medical Center Endocrinology and Diabetes

tomoakikunda@hotmail.com045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026