NCT07108985

Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors

Prospective, Open-label, Randomized, Parallel-group, Multicenter, Investigator, Initiated Phase 4 Clinical Trial to Evaluate the Glycemic Lowering Effects of Adding SGLT2 Inhibitor Monotherapy, TZD Monotherapy, or SGLT2 Inhibitor/TZD Combination Therapy in Patients With Type 2 Diabetes on DPP4 Inhibitors

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial investigates the effects of adding different diabetes medications to patients with type 2 diabetes who are currently being treated with DPP4 inhibitors. The study evaluates three treatment strategies: SGLT2 inhibitor monotherapy, TZD monotherapy, and a combination of both SGLT2 inhibitor and TZD. Participants will be randomly assigned to one of four groups, including a control group continuing DPP4 inhibitor alone. The primary objective is to assess changes in blood sugar control, specifically HbA1c levels, after 12 and 24 weeks of treatment. Secondary outcomes include changes in fasting and postprandial glucose, insulin, C-peptide, lipid profiles (total cholesterol, triglycerides, HDL-C, LDL-C), body composition (muscle mass, visceral fat, subcutaneous fat), and insulin resistance indicators such as HOMA-IR, HOMA-beta, and Insulinogenic Index. Eligible participants are adults aged 19 to 75 years with type 2 diabetes who have been on stable doses of DPP4 inhibitors, with or without metformin or sulfonylurea, for at least 8 weeks. Individuals with recent use of SGLT2 inhibitors or TZDs, significant organ dysfunction, or other exclusion criteria will not be enrolled. The study is open-label and multicenter, conducted at four hospitals in Korea. All medications used in the trial are provided by the sponsor. Participants will receive lifestyle counseling throughout the study period, including guidance on diet and exercise. Safety monitoring will be conducted regularly, and adverse events will be documented and managed according to protocol.

Conditions

• Diabetes Mellitus, Type 2
• Hyperglycemia
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Sitagliptin 100 mg	Sitagliptin 100 mg, taken once daily for 24 weeks.
DRUG	Sitagliptin 100 mg + Dapagliflozin 10 mg	Sitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks.
DRUG	Sitagliptin 100 mg + Dapagliflozin 10 mg	Sitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks.
DRUG	Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg	Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg, taken once daily for 24 weeks.

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-09-01
• Completion: 2030-08-31
• First posted: 2025-08-07
• Last updated: 2025-08-07

Locations

1 site across 1 country: South Korea