drugset / Trial / NCT07635953

New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes

NCT07635953

Phase 3 Not yet recruiting 296 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn the efficacy of combination therapy with tirzepatide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main objectives to achieve are: 1. To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM. 2. To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM Researchers will compare drug new triple combination therapy with tirzepatide, empagliflozin, and pioglitazone to standard therapy (metformin based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission. Participants will: 1. Take new triple combination therapy or a standard therapy every day for 6 months 2. Visit the clinic once every 0.5-1 month for checkups and tests 3. Keep a diary of their fingertip blood glucose and adverse events

Timeline

Start
2026-07-01
Primary completion
2029-07-01
Completion
2031-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 20 mg
Comparator Linagliptin Small molecule 5 mg
Comparator Metformin Small molecule 1000 mg
Subject Pioglitazone Small molecule 30 mg
Subject Tirzepatide Peptide 10 mg

Indications