Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first study

Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first study - MOSEL-fisrt study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035791

Enrollment

Registered

2019-02-06

Start date

2019-01-31

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

Type2 diabetes

Interventions

Metformin is started at 500 mg/day and increased to 2250 mg/day.24 weeks. Sitagliptin is started at 50 mg/day and increased to 100 mg/day when HbA1c at 12 weeks intervention is over 8.0%. 24 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 20 and 74 years 2. Patients treated by diet and exercise therapy 3. Patients who are not using hypoglycemic drugs at registration. 4. Over HbA1c 7.0%, under 11.0% at screening.

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes or secondary forms of diabetes. 2. Patients who have been administered hypoglycemic drugs by oral or injection by the time of registration. 3. Renal dysfunction (eGFRcr<45 ml/min/1.73m2). 4. Hepatic dysfunction (AST and/or ALT >3X upper limit of normal). 5. Patients with dehydration, chronic diarrhea. 6. Patients who developed ischemic heart disease within 6 months. 7. Malignant neoplasm (In case of follow-up in remission phase, registration is allowed). 8. Steroid(oral/injection) patients undergoing treatment. 9. Severe infection or injury. 10. Hypersensitivity to metformin, sitagliptin, or empagliflozin. 11. Pregnant or willing to be pregnant during this study. 12. Unable to obtain informed consent to this study. 13. Unable to maintain compliance during this study. 14. Patients judged unsuitable as subjects by doctor's judgment.

Design outcomes

Primary

Measure	Time frame
Difference of change in HbA1c at 24 weeks by metformin, sitagliptin and empagliflozin	—

Secondary

Measure	Time frame
Change in next items between baseline and 24,48,96weeks of treatment. 1. HbA1c 2. Glycated albumin 3. Fasting plasma glucose 4. Fasting C-peptide 5. creatinine 6. eGFR 7. Urine albumin/creatinine ratio(ACR) 8. TG 9. HDL-C 10. LDL-C 11. HOMA2%B 12. HOMA2-IR 13. Systolic blood pressure 14. Diastolic blood pressure 15. Pulse rate 16. Body weight 17. Medication compliance 18. Frequency of use(introduction)of insulin(Insulin is introduced in each group when blood glucose control is insufficient after the start of the study). 19. Stratified analysis on HbA1c variation(baseline HbA1c,BMI and age).	—

Measure

Time frame

Change in next items between baseline and 24,48,96weeks of treatment. 1. HbA1c 2. Glycated albumin 3. Fasting plasma glucose 4. Fasting C-peptide 5. creatinine 6. eGFR 7. Urine albumin/creatinine ratio(ACR) 8. TG 9. HDL-C 10. LDL-C 11. HOMA2%B 12. HOMA2-IR 13. Systolic blood pressure 14. Diastolic blood pressure 15. Pulse rate 16. Body weight 17. Medication compliance 18. Frequency of use(introduction)of insulin(Insulin is introduced in each group when blood glucose control is insufficient after the start of the study). 19. Stratified analysis on HbA1c variation(baseline HbA1c,BMI and age).

—

Countries

Japan

Contacts

Public ContactMarina Harada

Department of Endocrinology and Diabetes Department of Endocrinology and Diabetes

onyogora@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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