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)

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

Trial contacts and locations

Central trial contact

Data sourced from clinicaltrials.gov

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