A Phase IV Clinical Study to Compared the Efficacy and Safety of Switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes (TELOS)

Boryung

Status and phase: Not yet enrolling; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Dapagliflozin/Sitagliptin; Drug: Dapagliflozin/Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972732

BR-DPC-CT-401

Details and patient eligibility

About

This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.

Enrollment: 204 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has voluntarily agreed to participate in this clinical trial.
• Adults over 19 years of age
• Diagnosed with type 2 diabetes

Exclusion criteria

• Has severe renal and liver disorders
• Has type 1 diabetes
• Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study
• Those who are deemed ineligible to participate in the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Metformin + Dapagliflozin 10mg/Pioglitazone 30mg

Experimental group

Description:

One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.

Treatment:

Drug: Dapagliflozin/Pioglitazone

Drug: Metformin

Metformin + Dapagliflozin 10mg/Sitagliptin 100mg

Active Comparator group

Description:

One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.

Treatment:

Drug: Dapagliflozin/Sitagliptin

Drug: Metformin