New Triple Therapy in Newly Diagnosed Type 2 Diabetes

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Diabetes Mellitus
Interventions
DRUG

Group A (triple combination therapy group)

1\) Initiate with Semaglutide 0.25 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, if blood glucose is not controlled, adjust to Semaglutide 0.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. If Semaglutide is well-tolerated, increase to 1 mg qw after 1 week; 3)If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.

DRUG

Group B (standard therapy group)

metformin-based treatment is recommended when not contraindicated. 1).Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After another month, if blood glucose remains uncontrolled, add Semaglutide 0.25 mg qw, then increase to 0.5 mg qw after 1 month. If well-tolerated, increase to 1.0 mg qw after 1 week; 4) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.

Trial Locations (1)

510080

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER