Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study

Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study - DUET-beta study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024164

Enrollment

Registered

2016-11-29

Start date

2016-11-29

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

Dulaglutide 0.75mg/week, 24 weeks Trelagliptin 100mg/week, 24 weeks (CCr &lt

50ml/min/1.73m2, reduce dose to 50mg/week)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 20 and 85 years 2. Both gender 3. Treated with metformin +/- basal insulin 4. Stable treatment for diabetes over 8 weeks 5. Fasting plasma glucose level between 70 mg/dL and 180 mg/dL at screening 6. HbA1c less than 9.5% at screening

Exclusion criteria

Exclusion criteria: 1. Treated with incretin-based therapy 2. Type 1 diabetes or secondary forms of diabetes 3. Renal dysfunction (eGFR <35 ml/min/1.73m2) 4. Hepatic dysfunction (AST and/or ALT >3X upper limit of normal) 5. Malignant neoplasm 6. Severe infection or injury 7. Hypersensitivity to dulaglutide or trelagliptin 8. Pregnant or willing to be pregnant during this study 9. Unable to obtain informed consent to this study 10. Unable to maintain compliance during this study

Design outcomes

Primary

Measure	Time frame
Comparing the two groups of change in beta-cell function over the 24-week treatment period, measured using the disposition index.	—

Secondary

Measure	Time frame
Change in next items between baseline and 24 weeks of treatment. 1. HOMA2-%beta (%) 2. HOMA2-IR 3. CPR-index 4. Change in CPR during glucagon stimulation test 5. Area under the curve of C-peptide during glucagon stimulation test 6. HbA1c 7. Glycated alubumin 8. Fasting plasma glucose 9. Self-measured postprandial glucose 10. Systolic blood pressure 11. Diastolic blood pressure 12. Pulse rate 13. Lipid profile 14. eGFR 15. Urine albumin/creatinine ratio 16. Basal insulin dose 17. Body weight 18. Waist circumference 19. Fat mass 20. Skeletal muscle mass 21. Hypoglycemic events 22. Medication compliance 23. Other adverse events	—

Measure

Time frame

Change in next items between baseline and 24 weeks of treatment. 1. HOMA2-%beta (%) 2. HOMA2-IR 3. CPR-index 4. Change in CPR during glucagon stimulation test 5. Area under the curve of C-peptide during glucagon stimulation test 6. HbA1c 7. Glycated alubumin 8. Fasting plasma glucose 9. Self-measured postprandial glucose 10. Systolic blood pressure 11. Diastolic blood pressure 12. Pulse rate 13. Lipid profile 14. eGFR 15. Urine albumin/creatinine ratio 16. Basal insulin dose 17. Body weight 18. Waist circumference 19. Fat mass 20. Skeletal muscle mass 21. Hypoglycemic events 22. Medication compliance 23. Other adverse events

—

Countries

Japan

Contacts

Public ContactYoshinobu Kondo

Graduate School of Medicine, Yokohama City University Department of Endocrinology and Metabolism

kondo-ycu@zay.att.ne.jp045-787-2639

Outcome results

None listed

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