A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes

ConditionType 2 Diabetes

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age19+

SponsorBoryung Pharmaceutical Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has voluntarily agreed to participate in this clinical trial.

Adults over 19 years of age

Diagnosed with type 2 diabetes

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Metformin
Drug
The dosage and dose frequency are maintained as they were before the screening.
Dapagliflozin/Pioglitazone
Drug
Dapagliflozin 10mg/Pioglitazone 30mg QD
Dapagliflozin/Sitagliptin
Drug
Dapagliflozin 10mg/Sitagliptin 100mg QD

Treatment groups

204 Participants

are divided into 2 treatment groups

Group A: Metformin + Dapagliflozin 10mg/Pioglitazone 30mgExperimental treatment 2 interventions

Group B: Metformin + Dapagliflozin 10mg/Sitagliptin 100mgActive comparator 2 interventions

Trial outcomes

Primary outcomes

HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)

The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.

Time frame

From baseline to end of treatment at 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boryung Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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